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WASKYRA Etuvetidigene autotemcel 1000000 U/mL Injection, 20 mL — NDC 87668-0100-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

WASKYRA Etuvetidigene autotemcel 1000000 U/mL Injection, 20 mL — NDC 87668-0100-1 (Billing 87668-0100-01)

by Orphan Therapies LLC · 20 mL in 1 BAG

This is a package of 20 mL of WASKYRA Etuvetidigene autotemcel 1000000 U/mL Injection from Orphan Therapies LLC, marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 87668-0100-01
🏷️ FDA NDC (as labeled) 87668-0100-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 87668-0100-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
87668 labeler · 0100 product · 1 package
Package marketed since
Jul 23, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8766801001 6
FDA record last changed
Aug 6, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87668-0100-1
Product NDC 87668-0100
11-digit billing NDC 87668010001
RxCUI 2747661, 2747667
UNII SMN5E7TJ9C
Application # BLA125846
SPL Set ID 106880df-7a30-4a0f-9e16-9f20fcc7d138
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-23
Route INTRAVENOUS
Dosage form INJECTION
Substance ETUVETIDIGENE AUTOTEMCEL
Biologic (Purple Book) 351(a)
Quick answers
  • RxCUI (RxNorm): 2747661
Why two NDCs? The FDA registers this code as 87668-0100-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 87668-0100-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

📖 What it is MedlinePlus · NLM

Etuvetidigene autotemcel injection is used for the treatment of Wiskott-Aldrich Syndrome (WAS; a genetic disorder that causes immune system dysfunction) in patients who are candidates for hematopoietic stem cell transplant but do not have a matched related donor. Etudetidigene autotemcel is in a class of medications called gene therapies. It works by taking a patient's own blood stem cells and genetically modifying it in a lab to correct the gene that causes the immune system dysfunction and then infusing the corrected cells back into the patient so that healthy immune cells can be produced.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
87668-0100-01 You're viewing this Main listing 20 mL in 1 BAG 2026-07-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Waskyra 1000000 U/mL 87233-0100-01 Fondazione 20 ml — — FDA listed —
Waskyra 1000000 U/mLthis 87668-0100-01 Orphan 20 ml — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2025
First FDA approval
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 9, 2025 ⏳ ~11.2 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
waskyraetuvetidigene autotemcel
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateDec 9, 2037
Common questions
Is there a biosimilar for this drug?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII YOW8V9698H
    Dimethyl sulfoxide is a clear liquid solvent derived from wood pulp. In medicines, it helps dissolve or carry active ingredients and improve how the body absorbs the drug.
  • UNII ZIF514RVZR
    A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerOrphan Therapies LLC
FDA applicationBLA125846 (BLA)
Labeler code87668
First marketedJul 2026
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 118 words ▾

1 INDICATIONS AND USAGE WASKYRA ® is indicated for the treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. WASKYRA ® is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related hematopoietic stem cell donor is available.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For autologous use only. For single-dose intravenous use only. For autologous use only.

For intravenous use only. Patients are required to undergo hematopoietic stem and progenitor cell (HSPC) mobilization followed by apheresis to obtain CD34 + cells for WASKYRA ® manufacturing. ( 2.2 ) Dosing of WASKYRA ® is based on the number of CD34 + cells in the infusion bag(s) per kg of body weight at the time of infusion.

( 2.1 ) The minimum recommended dose is 7 x 10 6 CD34 + cells per kg. Reduced-intensity conditioning is required before infusion of WASKYRA ® . ( 2.2 ) Prior to WASKYRA ® infusion, confirm that the patient’s identity matches the essential unique patient information on the infusion bag(s).

( 2.3 )

2.1Recommended Dose The minimum recommended dose of WASKYRA ® is 7 × 10 6 CD34 + cells/kg based on patient’s body weight at the time of infusion. The maximum volume of WASKYRA ® to be administered should remain < 20% of the patient’s estimated plasma volume.

2.2Patient Preparation before WASKYRA ® Infusion Mobilization and apheresis Mobilize hematopoietic stem and progenitor cells (HSPC) using G-CSF with plerixafor according to established protocols. Perform apheresis to collect CD34+ cells required for WASKYRA ® manufacturing following the mobilization procedure. Collect and cryopreserve a back-up supply of CD34 + stem cells containing at least 3 x 10⁶ CD34 + cells/kg from the patient.

Complete this collection before initiating reduced intensity conditioning and WASKYRA ® infusion. Store the back-up collection for potential rescue treatment in the following scenarios: WASKYRA ® compromise after reduced intensity conditioning initiation but before scheduled infusion, primary engraftment failure, or prolonged bone marrow aplasia following WASKYRA ® treatment. Pre-treatment and conditioning Administer rituximab (anti-CD20 monoclonal antibody) approximately 22 days before WASKYRA ® administration to deplete autoreactive B-cells and provide pre-emptive treatment for potential lymphoproliferative disorder due to Epstein Barr Virus infection which is a risk factor in WAS patients.

Administer busulfan and fludarabine for reduced intensity conditioning before infusion of WASKYRA ® to promote engraftment of the genetically modified autologous CD34 + cells. Do not begin conditioning until the complete set of infusion bag(s) constituting the dose of WASKYRA ® has been received and stored at the administration site. Confirm availability of the back-up collection.

Premedication Administer intravenous chlorpheniramine (0.2 mg/kg, max. dose 10 mg), or an equivalent 15-30 minutes before the infusion of WASKYRA ® to reduce the possibility of an allergic reaction to the infusion.

2.3Administration Receipt WASKYRA ® is shipped in the vapor phase of liquid nitrogen (<-130°C; -202°F) from the manufacturing site to the qualified treatment center for the infusion. The Lot Information Sheet and the Chain of Custody documentation travels with the cryoshipper. Upon arrival check the temperature on the display of the cryoshipper, open it using the proper DPI, and confirm the patient code, batch number and number of bags against product label(s).

Transfer WASKYRA ® from the vapor phase of liquid nitrogen at less than -130°C (-202°F) to the treatment center vapor phase of liquid nitrogen storage (<-130°C; -202°F) until ready for thaw and administration. In the event of issues, contact Fondazione Telethon ETS at: 1-888-212-6928. Preparation for infusion WASKYRA ® contains human blood cells that are genetically modified with a replication-incompetent, self-inactivating lentiviral vector (LVV).

Follow universal precautions and local biosafety guidelines for handling and disposal of WASKYRA ® to avoid potential transmission of infectious diseases. Checking prior to thawing Do not remove the metal cassette from cryogenic storage or thaw WASKYRA ® until the patient is ready to be infused. Coordinate the timing of WASKYRA ® thaw a… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 117 words ▾

3 DOSAGE FORMS AND STRENGTHS WASKYRA ® is a single-dose cell suspension for intravenous infusion. WASKYRA ® is provided in one to eight infusion bags which contain 2–11.4 x 10 6 cells/mL (1.9–11.4 x 10 6 CD34 + cells/mL) [see How Supplied/Storage and Handling (16) ] . Each infusion bag contains 10 to 20 mL of WASKYRA ® .

The thawed product is colorless to yellow or pink and may be cloudy to clear. See the Lot Information Sheet for actual dose. WASKYRA ® is packaged in one to eight infusion bags overall containing a suspension of 2–11.4 x 10 6 cells /mL (1.9–11.4 x 10 6 CD34 + cells/mL) in a cryopreservative solution.

( 3 )

⛔ Contraindications 112 words ▾

4 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients [see Hypersensitivity and Infusion Related Reactions (5.1) ]. Previous treatment with HSCT within 6 months prior to treatment or HSCT with evidence of residual donor cells. Previous treatment with hematopoietic stem cell gene therapy.

Contraindications to the mobilization and the conditioning regimen. Hypersensitivity to the active substance or to any of the excipients. ( 4 ) Previous treatment with HSCT within 6 months prior to screening or HSCT with evidence of residual donor cell.

( 4 ) Previous treatment with hematopoietic stem cell gene therapy. ( 4 ) Contraindications to the mobilization and the conditioning regimen. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity and infusion-related reactions : Monitor patients for hypersensitivity and infusion-related reactions during and after infusion. ( 5.1 ) Engraftment failure : Monitor patients for signs and symptoms of engraftment failure. In case of engraftment failure, infuse the non-transduced back-up hematopoietic stem cells according to local standards.

( 5.2 ) Cytopenias : Severe cytopenias, including anemia, neutropenia, and thrombocytopenia have occurred for several weeks following reduced intensity conditioning and WASKYRA ® infusion. Monitor patients for signs and symptoms of cytopenia for at least 8 weeks after treatment with WASKYRA and manage accordingly. ( 5.3 ) Serious infections : Serious infections have occurred with WASKYRA ® administration.

Increased susceptibility to infections may occur due to concomitant administration of rituximab and conditioning regimen. Monitor patients for signs and symptoms of infection before and after WASKYRA infusion and treat appropriately. ( 5.4 ) Transmission of an infectious agent : All infections thought to be transmitted by WASKYRA ® should be reported to Fondazione Telethon ETS at 1- 888- 212- 6928.

( 5.5 ) Hepatic veno-occlusive disease : Monitor patients for signs and symptoms of veno-occlusive disease including assessment of liver function tests for one month after WASKYRA ® infusion ( 5.6 ) Risk of oncogenesis : There is a lifelong risk of lentiviral vector (LVV)-mediated insertional oncogenesis and secondary malignancy after treatment with WASKYRA ® . Monitor patients after treatment with WASKYRA ® for the development of malignancies. ( 5.7 ) Interference with HIV testing : Patients who have received WASKYRA ® may test positive by polymerase chain reaction (PCR) assays for HIV due to LVV provirus insertion, resulting in a false positive test for HIV.

Do not screen patients who have received WASKYRA ® for HIV infection using a PCR-based assay. ( 5.8 ) Blood, organ, tissue and cell donation : Patients treated with WASKYRA ® should not donate blood, organs, tissues and cells for transplantation at any time in the future. ( 5.9 )

5.1Hypersensitivity and Infusion Related Reactions Hypersensitivity and infusion related reactions, including anaphylaxis may occur with WASKYRA ® infusion due to DMSO as an excipient in WASKYRA ® . Monitor patients for signs and symptoms of hypersensitivity and infusion-related reactions during and after the WASKYRA ® infusion. When more than one bag of WASKYRA ® is needed, prior to infusion it should be ensured that the volume of product to be infused is compatible with the recommended limit of DMSO, i.e., the total volume of DMSO administered should remain < 1% of the patient’s estimated plasma volume.

The maximum volume of WASKYRA ® to be administered should therefore remain < 20% of the patient’s estimated plasma volume. Also, when more than one bag of WASKYRA ® is needed, only one bag of medicinal product should be infused at a time.

5.2Engraftment failure Engraftment failure defined as failure to reach an absolute neutrophil count (ANC) > 500 cells/μL associated with no evidence of bone marrow recovery (i.e., hypocellular marrow) by day 60 may potentially occur after WASKYRA ® infusion. Monitor patients for signs and symptoms of engraftment failure. In case of engraftment failure, infuse the non-transduced back-up hematopoietic stem cells according to local standards.

5.3Cytopenias Severe cytopenias, including anemia, neutropenia, and thrombocytopenia have occured for several weeks following reduced intensity conditioning and WASKYRA ® infusion [see Adverse Reactions (6.1) ] . Monitor patients for signs and symptoms of cytopenia for at least 8 weeks after treatment with WASKYRA ® . Manage patients with supportive transfusion according to clinical practice.

If neutropenia persists beyond six to seven weeks after WASKYRA ® infusion, despite the use of granulocyte colony – stimulating factor, consider administrat… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 20%) are catheter related infections, bacterial and viral infections, diarrhea, vomiting, stomatitis, liver injury, head injury, rhinitis, cough, rash, petechiae, hypersensitivity, anemia, febrile neutropenia, epistaxis, pyrexia, catheter site complications. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fondazione Telethon ETS at toll-free phone 1-888-212-6928 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflects exposure to WASKYRA ® in two clinical studies, Study 1 (201228) and Study 2 (OTL-103-4) as well as patients in expanded access program (EAP). A total of 27 patients received a single infusion of WASKYRA ® at a dose range of 7 to 31×10 6 CD34 + cells/kg (median dose: 16.90×10 6 CD34 + cells/kg).

The median duration of the follow up was 5.67 years (range: 0.37-13.26 years) [see Clinical Studies (14) ]. During the above-mentioned clinical trials no adverse reactions attributable to the gene therapy were reported. There were 45 serious adverse reactions reported in 21 patients including catheter-related infections (n=11), bacterial and viral infections (n=10), pyrexia (n=3), prolonged neutropenia (n=2), vomiting (n=2), veno-occlusive disease (n=1), aspergillus infection (n=1).

One patient died approximately 4.5 months after WASKYRA ® infusion due to neurological decompensation. Table 1: Adverse Reactions Occurring in ≥10% of Patients (N=27) Adverse Reactions Any Grade n (%) Grade 3 or higher n (%) Infections and Infestations - - Catheter related infection 16 (59) 14 (52) Respiratory tract infection Is a composite that includes multiple related terms. 18 (67) 4 (15) Conjunctivitis * 10 (37) 0 Cytomegalovirus infection * 8 (30) 4 (15) Epstein-Barr virus infection 5 (19) 1 (4) Gastroenteritis 5 (19) 2 (7) Ear infection 4 (15) 0 Oral candidiasis 4 (15) 0 Urinary tract infection * 5 (19) 3 (11) Balanoposthitis 3(11) 0 Gastrointestinal disorders - - Diarrhea * 16 (59) 3 (11) Vomiting 12 (44) 5 (19) Liver injury * 16 (59) 3 (11) Stomatitis 6 (22) 3 (11) Hematochezia 5 (19) 0 Abdominal pain 3 (11) 0 Constipation 3 (11) 0 Nervous System disorders - - Head Injury* 10 (37) 1 (4) Headache 4 (15) 2 (7) Respiratory, thoracic and mediastinal disorders - - Rhinitis 9 (33) 0 Cough * 8 (30) 0 Wheezing 4 (15) 0 Oropharyngeal pain 3 (11) 1 (4) Skin and subcutaneous tissue disorders - - Rash Rash includes eczema, rash, urticaria, dermatitis, dry skin, erythema.

23 (85) 9 (33) Petechiae 16 (59) 1 (4) Immune system disorders - - Hypersensitivity * 6 (22) 4 (15) Lymphadenopathy 4 (15) 1 (4) Blood and lymphatic system disorders - - Anemia * 11 (41) 4 (15) Immune thrombocytopenia 4 (15) 4 (15) Febrile neutropenia 7 (26) 6 (22) Epistaxis 9 (33) 0 Mouth hemorrhage 3 (11) 0 Traumatic hematoma * 4 (15) 0 General disorders and administration site conditions - - Pyrexia 11 (41) 6 (22) Catheter site complications Catheter site complications includes Catheter site inflammation, Catheter site hemorrhage, Unintentional medical device removal.

10 (37) 1 (4) Note: Adverse reactions are defined as adverse events occurred during conditioning and year 1 following WASKYRA ® administration. Other clinically significant adverse reactions that occurred in < 20% patients include papillary thyroid cancer diagnosed in one patient with a familial history of Graves' disease at 5-years post treatment. The tumor cells did not contain viral vector gene sequences.

Table 2. Laboratory Abnormalities that Worsened from Baseline in ≥ 10% of Patients (N=27) Laboratory Abnormality All Grade n (%) Grade 3 or 4 n (%) Neutrophils decreased 10 (37) 9 (33) Eosinophils increas… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 146 words ▾

7 DRUG INTERACTIONS No formal drug interaction studies have been performed. WASKYRA ® is not expected to interact with the hepatic cytochrome P-450 family of enzymes or drug transporters.

7.1Effect of Vaccines on WASKYRA ® The safety and effectiveness of vaccination during or following WASKYRA ® treatment have not been studied. Vaccination with live virus vaccines is not recommended until immune reconstitution is completed following treatment with WASKYRA ® .

7.2Effect of Anti-retrovirals on WASKYRA ® Anti-retroviral medications may interfere with the manufacturing of WASKYRA ® . Patients should not take anti-retroviral medications for at least one month prior to mobilization until at least 7 days after WASKYRA ® infusion. If a patient requires anti-retroviral treatment following exposure to HIV/HTLV, initiation of WASKYRA ® treatment should be delayed until an HIV/HTLV western blot and viral load assay have been performed at 6 months post-exposure.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no clinical data from the use of WASKYRA ® in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with WASKYRA to assess whether it can cause fetal harm when administered to a pregnant woman. WASKYRA ® must not be administered during pregnancy because of the risk associated with conditioning.

Pregnancy after WASKYRA ® infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary There are no data on the presence of WASKYRA ® in human or animal milk, the effects on the breastfed child, or the effects on milk production. Because of the potential risks associated with conditioning, breast-feeding should be discontinued during conditioning. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for WASKYRA ® and any potential adverse effects on the breastfed child from WASKYRA ® or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential The safety of WASKYRA ® was only evaluated in male patients. Pregnancy Testing A negative serum pregnancy test must be confirmed prior to the start of mobilization and re-confirmed prior to conditioning procedures and before administration of WASKYRA ® in females of childbearing potential. Contraception Males capable of fathering a child and females of childbearing age should use an effective method of contraception from start of mobilization through at least 6 months after administration of WASKYRA ® .

Infertility There is no data on the effects of WASKYRA ® on fertility. Consult the Prescription Information of the conditioning medicinal products. It should be noted that the treating physician should inform the patients or the patient’s parents/carers in case of minors about options for cryopreservation of spermatogonial stem cells or ovarian tissue prior to application of conditioning.

8.4Pediatric Use The safety and efficacy of WASKYRA ® for the treatment of WAS have been established in pediatric patients aged 6 months and older. The use of WASKYRA ® in pediatric patients is supported by evidence from Study 1, Study 2, and patients in expanded access program which included 25 pediatric patients 1 to 16 years of age [see Adverse Reactions (6) and Clinical Studies (14) ]. The safety and effectiveness of WASKYRA ® have not been established in pediatric patients younger than 6 months of age.

🤰 Pregnancy 95 words ▾

8.1Pregnancy Risk Summary There are no clinical data from the use of WASKYRA ® in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with WASKYRA to assess whether it can cause fetal harm when administered to a pregnant woman. WASKYRA ® must not be administered during pregnancy because of the risk associated with conditioning.

Pregnancy after WASKYRA ® infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

🧒 Pediatric Use 89 words ▾

8.4Pediatric Use The safety and efficacy of WASKYRA ® for the treatment of WAS have been established in pediatric patients aged 6 months and older. The use of WASKYRA ® in pediatric patients is supported by evidence from Study 1, Study 2, and patients in expanded access program which included 25 pediatric patients 1 to 16 years of age [see Adverse Reactions (6) and Clinical Studies (14) ]. The safety and effectiveness of WASKYRA ® have not been established in pediatric patients younger than 6 months of age.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action WASKYRA ® adds full-length copies of the human WAS complementary deoxyribonucleic acid (cDNA) into patients’ hematopoietic stem cells (HSCs) through transduction with WAS lentiviral vector (LVV). After infusion, the genetically modified cells engraft in the bone marrow, repopulate the hematopoietic compartment, and produce biologically active lymphoid and myeloid progenitors whose progeny express WAS protein (WASP). WASP regulates the structural protein actin in blood cells.

12.2Pharmacodynamics No dedicated clinical pharmacology studies have been conducted to study pharmacodynamics. The presence of gene-corrected HSPCs in BM and peripheral blood has been assessed at different time points after treatment with WASKYRA ® : Engraftment of gene corrected cells was observed from 1 month post- WASKYRA ® administration and throughout post-treatment follow-up, in all evaluated participants up to 9 years after GT, as indicated by VCN values in bone marrow and peripheral blood cell lineages above the protocol-defined target of 4% in BM-derived CD34 + cells and 10% in PB derived CD3 + cells.

The presence of the WAS transgene resulted in the restoration of WASP expression in the hematopoietic compartment of all subjects, with a > 65% at 1 year of follow up in lymphocytes and > 74% at 30 days follow up in platelets stably expressing WASP. Reconstitution of WASP expression in turn led to improved platelet counts, ultrastructure and activation profile, as well as restored immune cell functions in treated subjects.

12.3Pharmacokinetics WASKYRA ® is an autologous gene therapy which includes hematopoietic stem cells (HSCs) that have been genetically modified ex vivo. The nature of WASKYRA ® is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.

🧬 Mechanism of Action 68 words ▾

12.1Mechanism of Action WASKYRA ® adds full-length copies of the human WAS complementary deoxyribonucleic acid (cDNA) into patients’ hematopoietic stem cells (HSCs) through transduction with WAS lentiviral vector (LVV). After infusion, the genetically modified cells engraft in the bone marrow, repopulate the hematopoietic compartment, and produce biologically active lymphoid and myeloid progenitors whose progeny express WAS protein (WASP). WASP regulates the structural protein actin in blood cells.

📦 How Supplied / Storage and Handling 197 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING WASKYRA ® is supplied in 1 to 8 infusion bags containing a frozen suspension of genetically modified autologous cells enriched for CD34 + cells. Each bag contains 10 to 20 mL of suspension. Infusion bags consist of a 50 mL ethylene vinyl acetate (EVA) bag(s) with two available spike ports, packed in an EVA overwrap bag placed inside a metal cassette.

WASKYRA ® is shipped from the manufacturing facility to the treatment center storage facility in a cryoshipper, which may contain multiple metal cassettes intended for a single patient. Each metal cassette contains one infusion bag with WASKYRA ® . A Lot Information Sheet and the Chain of Custody/Chain of Identity is included with the cryoshipper.

50mL infusion bag, overwrap, and metal cassette (NDC 87668-0100-1). Match the identity of the patient with the patient identifiers, and Lot Information Sheet upon receipt. Store WASKYRA ® in the vapor phase of liquid nitrogen at less than -130°C (-202°F) until ready for thaw and administration.

Thaw WASKYRA ® prior to infusion [see Dosage and Administration (2) ] . Do not re-freeze after thawing. Do not irradiate WASKYRA ® , as this could lead to inactivation.

📋 Description 156 words ▾

11 DESCRIPTION WASKYRA ® (etuvetidigene autotemcel) is an autologous hematopoietic stem cell-based gene therapy for intravenous infusion. WASKYRA ® is prepared from the patient’s own hematopoietic stem cells (HSCs), which are collected using apheresis procedure(s). The autologous cells are enriched for CD34 + cell and then transduced ex vivo with a replication incompetent self-inactivating (SIN) human immunodeficiency virus-1 (HIV-1)-based lentiviral vector (LVV) that has been modified to carry the WAS gene sequence under the control of the human WAS promoter.

The transduced CD34 + cells are washed, formulated into a suspension, and then cryopreserved. WASKYRA ® is manufactured for each individual patient into infusion bags, which are cryopreserved before being thawed prior to administration [see Dosage and Administration (2.3) , How Supplied/Storage and Handling (16) ] . The formulation contains 7% (w/v) human serum albumin (HSA) and 5% (v/v) dimethyl sulfoxide (DMSO).

Each 1mL of WASKYRA ® suspension for IV infusion contains 3.5 mg of sodium.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Ensure that patients and/or caregivers understand the risk of manufacturing failure. A collection of unmanipulated back-up CD34 + cells is required in case of manufacturing failure. These cells must be collected from the patient and be cryopreserved prior to conditioning.

Prior to treatment, discuss following with the patients and/or caregivers: Risk of hypersensitivity reactions - Although no cases have been reported to date, allergic reactions may occur with the infusion of WASKYRA ® . The DMSO in WASKYRA ® may cause hypersensitivity reactions, including anaphylaxis [see Warnings and Precautions (5.1) ] . Failure of engraftment is a potentially important risk [see Warnings and Precautions (5.2) ] .

Risks of severe cytopenias. Patients should be monitored for signs and symptoms of cytopenia for at least 6 weeks after infusion [see Warnings and Precautions (5.3) ] . Risk of serious infections have occurred with WASKYRA ® administration [see Adverse Reactions (6.1) ].

Increased susceptibility to infections may occur to concomitant administration of rituximab and conditioning regimen. Patients should be monitored for signs and symptoms of infection before and after WASKYRA ® infusion and treat appropriately. Any blood product required after WASKYRA ® infusion should be irradiated ( 5.4 ).

Risk of transmission of infectious agents may occur. Monitor patients for signs and symptoms of infection [see Warnings and Precautions (5.5) ] . Risk of hepatic veno-occlusive disease may occur.

Monitor patients for signs and symptoms of veno-occlusive disease [see Warnings and Precautions (5.6) ] . Oncogenesis - There is a potential risk of insertional oncogenesis after treatment with WASKYRA ® . Patients should be monitored lifelong.

Monitoring will include assessment for hematologic malignancies annually for at least 15 years after treatment with WASKYRA ® . This will include integration site analysis as warranted [see Warnings and Precautions (5.7) ] . Interference with HIV testing - Patients who have received WASKYRA ® may test positive by polymerase chain reaction (PCR) assays for HIV.

Patients who have received WASKYRA ® should not be screened for HIV infection using a PCR-based assay [see Warnings and Precautions (5.8) ] . Blood, organ, tissue and cell donation - Patients treated with WASKYRA ® should not donate blood, organs, tissues and cells for transplantation at any time in the future [see Warnings and Precautions (5.9) ] . Advise patients and/or caregivers to: Have their treating physician contact Fondazione Telethon at 1-888-212-6928 if they are diagnosed with a malignancy [see Warnings and Precautions (5.7) ] .

Advise patients and/or caregivers that patients should not donate blood, organs, tissues, or cells at any time in the future [see Dosage and Administration (2.3) ] . Advise patients and/or caregivers that treatment with WASKYRA ® may cause a false-positive human immunodeficiency virus (HIV) test result if tested using a PCR assay [see Warnings and Precautions (5.10)] . Manufactured for: Fondazione Telethon ETS Via Varese 16/B 00185 Rome Italy US License No 2378

🧬 Pharmacokinetics 42 words ▾

12.3Pharmacokinetics WASKYRA ® is an autologous gene therapy which includes hematopoietic stem cells (HSCs) that have been genetically modified ex vivo. The nature of WASKYRA ® is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.

🧬 Pharmacodynamics 166 words ▾

12.2Pharmacodynamics No dedicated clinical pharmacology studies have been conducted to study pharmacodynamics. The presence of gene-corrected HSPCs in BM and peripheral blood has been assessed at different time points after treatment with WASKYRA ® : Engraftment of gene corrected cells was observed from 1 month post- WASKYRA ® administration and throughout post-treatment follow-up, in all evaluated participants up to 9 years after GT, as indicated by VCN values in bone marrow and peripheral blood cell lineages above the protocol-defined target of 4% in BM-derived CD34 + cells and 10% in PB derived CD3 + cells.

The presence of the WAS transgene resulted in the restoration of WASP expression in the hematopoietic compartment of all subjects, with a > 65% at 1 year of follow up in lymphocytes and > 74% at 30 days follow up in platelets stably expressing WASP. Reconstitution of WASP expression in turn led to improved platelet counts, ultrastructure and activation profile, as well as restored immune cell functions in treated subjects.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of WASKYRA ® was evaluated in two clinical studies, Study 1 (201228; NCT01515462 ) and Study 2 (OTL-103-4; NCT03837483 ) as well as in patients from an expanded access program (EAP). Study 1 was a prospective, open-label, single-arm, single-center study (n=8) that evaluated the safety and efficacy of WASKYRA ® fresh formulation compared to 12-month pre-treatment outcomes. Study 2 is an ongoing, open-label, single-arm, multicenter study (n=10) evaluating the efficacy of WASKYRA ® cryopreserved formulation compared to 12-month pre-treatment outcomes.

The expanded access program included Hospital Exemption (HE) 205030 (n=3), and Compassionate Use Program (CUP) 206257 (n=6) which provided WASKYRA treatment to patients with WAS. The studies and the expanded access program enrolled patients who had a diagnosis of WAS confirmed by genetic mutation and at least one of the following criteria: 1) severe clinical score (Zhu clinical score ≥ 3), 2) severe WAS mutation, or 3) absent WASP expression. All patients lacked a suitable human leukocyte antigen (HLA)-matched donor.

Patients with prior allogeneic hematopoietic stem-cell transplantation (HSCT) within 6 months or evidence of residual cells of donor origin, prior gene therapy, human immunodeficiency virus (HIV) infection and cytogenetic alterations were excluded. Patients underwent hematopoietic stem-cell (HSC) collection by bone marrow collection (n=5), from apheresis following the administration of HSC mobilizing agents (n=21), or from both sources (n=1). Prior to treatment, patients received rituximab and a conditioning regimen with busulfan, and fludarabine.

Rituximab was administered as a single dose of 375 mg/m² on Day –22 (+/-1). Busulfan was given in eight doses every 6 hours from Days -4 to -2, with dosing adjusted based on pharmacokinetic monitoring to achieve a target cumulative AUC of 48,000±10% ng/mL per hour. Fludarabine was given at a total dose of 60 mg/m², split into two doses on Days -4 and -3.

Patient then received a single infusion of WASKYRA ® through a central venous access at a dose range of 7–31×10 6 /kg CD34 + cells (median dose: 16.90×10 6 /kg). The demographic characteristics were as follows: median age was 2.6 years (range 1 to 35 years), all patients (100%) were male, 20 patients (74%) were White, 4 patients (15%) were Asian, 2 patients (7%) were African American, and 1 patient was American Indian or Alaska Native. Three patients (11%) were Hispanic or Latino.

Twenty-six out of 27 patients were included in efficacy evaluation. One patient did not receive WASKYRA treatment due to mobilization failure and was excluded from the analyses. The major efficacy outcomes were the rate of severe infections during the 6 to 18 month period after WASKYRA ® infusion compared with the 12-month pre-treatment period, and the rate of moderate or severe bleeding episodes during the 12-month period after WASKYRA ® infusion compared with the 12-month pre-treatment period.

The rate of severe infections decreased from 2.0 (95% CI: 1.50, 2.61) infections per patient year observation (PYO) in the 12 months pre-treatment period to 0.2 (95% CI: 0.04, 0.40) per PYO infections in 6-18 months post-gene therapy. The rate of moderate and severe bleeding events decreased from 2.0 (95% CI: 1.50, 2.61) events per PYO in the 12 months pre-treatment to 0.8 (95% CI: 0.49, 1.22) events per PYO in the 12 months after WASKYRA ® treatment.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No mutagenicity, carcinogenicity and reproductive and developmental toxicity studies have been performed with WASKYRA ® . In vitro immortalization (IVIM) experiments with WAS lentiviral vector (LVV) transduced mouse Lin- BM cells, vector insertion site analyses (VISA) with WAS patient and healthy donor HSPCs in vitr o and in vivo after engraftment in immunodeficient Rag2 −/− γc −/− mice and a vector integration tag analysis (VITA) study in disease model mice showed no evidence for clonal proliferation and no genotoxic potential.

Toxicity studies were performed in vivo in two different WAS knock-out mouse models transplanted with Lin- BM cells transduced with WAS LVV. Investigations included follow-up for at least 12 months post-transplant in one model and serial transplant studies in the second model covered a cumulative period of 10 months (4+6). These studies demonstrated normal engraftment, differentiation and seeding of lymphoid tissues with no adverse clinical signs, mortalities and no pathologic changes related to the integration of WAS LVV.

No toxicity and no increase in tumorigenesis occurred in either model. The WAS protein was not overexpressed, even at high VCNs, and no toxicity due to protein overexpression has been observed.

13.2Animal Toxicology and/or Pharmacology Additional studies with human CD34 + cells transduced with WAS LVV administered to immunodeficient, myeloablated mice demonstrated no toxicity, no replication competent lentivirus (RCL), no vector mobilization and no secondary transduction of bystander cells, including male gonads.

📄 Package Label / Principal Display Panel 113 words ▾

Principal Display Panel - -Infusion bag NDC: 87668-0100-1 etuvetidigene autotemcel Waskyra ® 1.9 -11.4 x 10 6 CD34+ cells /mL dispersion for infusion Rx only. Intravenous use. For autologous use only. cryopreservative solution containing 5% DMSO Store and transport frozen (<-130°C) infusionbag

Principal Display Panel - Metal cassette etuvetidigene autotemcel Waskyra ® 1.9 -11.4 x 10 6 CD34+ cells /mL dispersion for infusion Rx only NDC: 87668-0100-1 metalcassette

Principal Display Panel - Over wrap bag etuvetidigene autotemcel Waskyra ® 1.9 -11.4 x 10 6 CD34+ cells /mL dispersion for infusion 10-20 mL. Rx only. For intravenous use. For autologous use only. Keep out of the sight and reach of children. NDC: 87668-0100-1 overwrapbag

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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