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OTARMENI lunsotogene parvec-cwha 30000000000000 {GC}/mL Injection, Solution, 1 vial — NDC 61755-0062-99 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

OTARMENI lunsotogene parvec-cwha 30000000000000 {GC}/mL Injection, Solution, 1 vial — NDC 61755-062-99 (Billing 61755-0062-99)

by Regeneron Pharmaceuticals, Inc. · 1 CARTON in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of OTARMENI lunsotogene parvec-cwha 30000000000000 {GC}/mL Injection, Solution from Regeneron Pharmaceuticals, Inc., marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 61755-0062-99
🏷️ FDA NDC (as labeled) 61755-062-99 billing pads the product 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 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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 61755-062-99 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61755 labeler · 062 product · 99 package
Package marketed since
Apr 23, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6175506299 7
FDA record last changed
Aug 20, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61755-062-99
Product NDC 61755-062
11-digit billing NDC 61755006299
RxCUI 2741622, 2741629
UNII P6ZNU67HPU
Application # BLA125874
SPL Set ID a7a5e936-ab4a-4609-ac10-96efedc89035
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-23
Route INTRACOCHLEAR
Dosage form INJECTION, SOLUTION
Substance LUNSOTOGENE PARVEC

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 088880
GCN 59063
HICL code 051281
Ingredient (HICL) Lunsotogene Parvec-Cwha
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q1
Therapeutic class — intermediate (HIC2) Drugs Acting On The Ear
HIC3 code Q1B
Therapeutic class — specific (HIC3) Otic Cell/Gene Therapy Agents
AHFS code 26:12.00.00
AHFS class Gene Therapy
FDB label name OTARMENI VIAL
FDB brand name Otarmeni
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088880
  • GCN: 59063
  • HICL (First Databank): 051281
  • AHFS class code: 26:12.00.00
  • RxCUI (RxNorm): 2741622
Why two NDCs? The FDA registers this code as 61755-062-99 — a 5-3-2 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 product segment → 61755-0062-99. 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

Label name OTARMENI VIAL Ingredient Lunsotogene Parvec-Cwha
📖 What it is MedlinePlus · NLM

Lunsotogene is used to treat certain types of inherited hearing loss. Lunsotogene is in a class of medications called gene therapy. It works by helping to produce a protein to restore function of a nerve that is necessary for hearing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Otarmeni delivers a working copy of the OTOF gene directly into your inner ear so your hearing cells can finally make the protein they were missing. In the clinical trial, many pat...
  • What exactly does this treatment do — is it a cure?
  • Yes — Otarmeni is given through a surgical procedure under general anesthesia, so you'll be asleep for it. A specially trained surgeon makes a small opening to access your inner ea...
  • Is this a surgery? What will the procedure be like?
📖 Read our full Lunsotogene Parvec-Cwha guide →

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 mLPer 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
61755-0062-99 You're viewing this Main listing 1 CARTON in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2026-04-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Otarmeni 30000000000000 {GC}/mLthis 61755-0062-99 Regeneron 1 vial — — 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

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

🧪 Avoiding an ingredient? See Lunsotogene Parvec-Cwha inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII LQA7B6G8JG
    A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
  • 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.
  • UNII 70WT22SF4B
    A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
  • UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 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

LabelerRegeneron Pharmaceuticals, Inc.
FDA applicationBLA125874 (BLA)
Labeler code61755
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio27 products on file

More NDCs from Regeneron Pharmaceuticals, Inc. labeler code 61755

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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE OTARMENI is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. This indication is approved under accelerated approval based on the improvement of hearing sensitivity assessed by average pure tone audiometry (PTA) at Week 24 [see Clinical Studies (14) ] .

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory clinical trial. Limitations of Use OTARMENI is not recommended in patients in whom preoperative imaging demonstrates that access to the inner ear is not feasible including those with abnormal mastoid pneumatization or clinically significant anatomic variations of the middle ear and inner ear. OTARMENI is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear.

( 1 ) This indication is approved under accelerated approval based on the improvement of hearing sensitivity assessed by average pure tone audiometry (PTA) at Week 24. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory clinical trial. ( 1 , 14 ) Limitations of Use OTARMENI is not recommended in patients in whom preoperative imaging demonstrates that access to the inner ear is not feasible including those with abnormal mastoid pneumatization or clinically significant anatomic variations of the middle ear and inner ear.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intracochlear infusion only. Recommended dose of OTARMENI for each ear is 7.2 × 10 12 vector genomes (vg) in a total volume of 0.24 mL, administered by a single-dose intracochlear infusion. ( 2.2 )

2.1Critical Dosing and Administration Information Confirm patient has biallelic, likely pathogenic or pathogenic OTOF variants. OTARMENI should be administered by a surgeon experienced in intracochlear surgery and trained in the administration procedure. Administer bilateral OTARMENI, if applicable, in a single surgical session.

For prophylaxis against inflammatory and immunological responses, administer systemic oral corticosteroids equivalent in strength to prednisone at 1 mg/kg/day the day of the OTARMENI infusion, maintain the same dose for two weeks, and taper over the following two weeks. The total corticosteroid dose should not exceed 60 mg/day. For prophylaxis against post-operative infection, administer antibiotics before incision.

Administer age-appropriate vaccination prior to treatment with OTARMENI. Administer vaccines at least 1 month before the first corticosteroid dose and at least 1 month after the last dose. Vaccinate patients against micro-organisms that cause meningitis before surgery as meningitis is a known risk of inner ear surgery.

2.2Recommended Dosage For intracochlear infusion only. The recommended dose of OTARMENI for each ear is 7.2 × 10 12 vector genomes (vg) in a total volume of 0.24 mL, administered by a single-dose intracochlear infusion.

2.3Preparation Prepare syringe containing OTARMENI using sterile technique under aseptic conditions in a Class II biological safety cabinet (BSC). Administer OTARMENI within 4 hours of puncturing the vial. Below is the list of items required for administration syringe preparation.

Confirm component packaging and inspect each item prior to use and do not use if any damage is identified. One single-dose vial of OTARMENI in a sealed barrier bag (package 1 of 2) [see How Supplied/Storage and Handling (16) ] Administration Kit for use with OTARMENI (package 2 of 2) [see How Supplied/Storage and Handling (16) ] Not supplied but required: One isopropyl alcohol pad One sterile sealable plastic bag Secondary container for delivery to surgical suite Label and a pen Preparation of OTARMENI for Infusion For each treated ear, thaw one single-dose vial of OTARMENI at room temperature.

The contents of the vial will thaw in approximately 30 minutes at room temperature. DO NOT thaw or warm the vial any other way. Gently invert the vial 5 times (DO NOT shake or vortex the vial).

Inspect the OTARMENI vial to ensure that it is thawed, clear to slightly opalescent, and that the vial has no signs of damage. If there is any evidence of cloudiness, particulates, or color, do not use the vial. If not used immediately, store the unpunctured thawed vial in the refrigerator for up to 24 hours or at room temperature for up to 8 hours.

Choose the smallest compatible syringe size, either 1 mL or 3 mL included in the kit, according to the syringe pump parameters. Discard the unused syringe. Do not open the catheter sterile packaging until transferred to the surgical suite.

Prepare the septum of the OTARMENI vial using an isopropyl alcohol pad to wipe the top. Wait for the septum to dry. Secure the 21G, 1.5-inch needle onto the 1 mL or 3 mL syringe.

When filling the syringe for administration, push the needle until it is completely inserted into the vial and the tip touches the bottom edge of the upright vial. Administer OTARMENI within 4 hours of puncturing the vial. Withdraw all OTARMENI vial contents into the syringe.

Tilt the vial to ensure complete withdrawal. Confirm that at least 0.6 mL is available in the syringe. To prevent the introduction of air, keep the needle bevel submerged in the liquid at the bottom edge of the vial by orienting the bevel towards the vial wall (Figure 1).

Figure 1: Holding the syringe with the needle pointing up, check the syringe… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 100 words ▾

3 DOSAGE FORMS AND STRENGTHS OTARMENI is a sterile suspension for intracochlear infusion. Each single-dose vial contains a nominal titer of 3.0 × 10 13 vg/mL of OTARMENI and has an extractable volume of 0.63 mL. Following product thaw, the suspension for infusion is a clear to slightly opalescent, colorless liquid, free of visible particulates [see How Supplied/Storage and Handling (16) ] .

OTARMENI is a sterile suspension for intracochlear infusion. ( 3 ) Each single-dose vial contains a nominal titer of 3.0 × 10 13 vg/mL of OTARMENI and has an extractable volume of 0.63 mL. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 72 words ▾

5 WARNINGS AND PRECAUTIONS Procedure-Related Risks: Monitor patients for procedure-related adverse reactions with OTARMENI administration. ( 5.1 )

5.1Procedure-Related Risks Procedure-related adverse reactions may occur with OTARMENI administration including vertigo, tinnitus, cerebral spinal fluid leak, ipsilateral facial paresis, ipsilateral change in taste, meningitis, wound infection, mastoiditis, numbness around the ear, blood or fluid collection at surgical site, and labyrinthitis. Monitor patients for procedure-related adverse reactions with OTARMENI administration and manage accordingly.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥5%) include otitis media, vomiting, nausea, dizziness, procedural pain, gait disturbance, and nystagmus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-866-500-GENE 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 reflect exposure to OTARMENI in one study (Study DB-OTO-001) which treated 24 patients with OTOF gene associated profound sensorineural hearing loss. A total of 10 patients received unilateral dosing, and a total of 14 patients received bilateral dosing of OTARMENI at a nominal dose of 7.2 × 10 12 vg per ear.

The median duration of follow-up was 45 weeks (range 9 to 115 weeks) [see Clinical Studies (14) ] . Table 1 lists the most common adverse reactions that occurred in ≥ 5% patients in Study DB-OTO-001. Table 1: Adverse Reactions Occurring in ≥5% of Patients in Study DB-OTO-001 (N=24) Adverse Reaction Overall n (%) Otitis Media 9 (38) Vomiting 8 (33) Nausea 7 (29) Dizziness 5 (21) Procedural Pain 4 (17) Gait Disturbance 2 (8) Nystagmus 2 (8) Other clinically significant adverse reactions each occurring in 1 patient included transient balance disorder (4%), abnormal otoacoustic emissions (4%), and wound dehiscence (4%).

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no data from the use of OTARMENI in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with OTARMENI. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary There are no data on the presence of OTARMENI in human milk, the effects on the breastfed infant, or the effects on milk production.

8.3Females and Males of Reproductive Potential Pregnancy Testing Pregnancy status of females with reproductive potential should be verified. Sexually active females of reproductive potential should have a negative pregnancy test before administering OTARMENI. Contraception There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with OTARMENI.

Infertility There are no data on the effects of OTARMENI on fertility.

8.4Pediatric Use The safety and effectiveness of OTARMENI have been established in pediatric patients with OTOF gene associated profound sensorineural hearing loss. The use of OTARMENI was supported by evidence from one clinical study that treated 24 pediatric patients aged 10 months to 16 years [see Adverse Reactions (6) and Clinical Studies (14) ] .

8.5Geriatric Use OTARMENI has not been studied in patients 65 years of age and older.

🤰 Pregnancy 56 words ▾

8.1Pregnancy Risk Summary There are no data from the use of OTARMENI in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with OTARMENI. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

🧒 Pediatric Use 56 words ▾

8.4Pediatric Use The safety and effectiveness of OTARMENI have been established in pediatric patients with OTOF gene associated profound sensorineural hearing loss. The use of OTARMENI was supported by evidence from one clinical study that treated 24 pediatric patients aged 10 months to 16 years [see Adverse Reactions (6) and Clinical Studies (14) ] .

🧓 Geriatric Use 16 words ▾

8.5Geriatric Use OTARMENI has not been studied in patients 65 years of age and older.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Intracochlear infusion of OTARMENI results in expression of the OTOF gene primarily in inner hair cells (IHCs), which facilitates production of functional otoferlin protein and restores synaptic transmission to the auditory nerve as shown in animal studies in mice.

12.2Pharmacodynamics There are no pharmacodynamics data for OTARMENI.

12.3Pharmacokinetics Biodistribution (within the body) and Vector Shedding (excretion/secretion) OTARMENI vector DNA levels in various matrices and nonclinical tissues were determined using a qualified quantitative polymerase chain reaction (qPCR) assay. Expression of human OTOF mRNA was determined in selected nonclinical tissues. Nonclinical data Systemic distribution of vector DNA was evaluated in cynomolgus monkeys at weeks 7 and 27 after a single bilateral intracochlear infusion of dose levels up to 4.4 × 10 12 vg/ear (7.3 × 10 13 vg/mL), and in juvenile mice at days 30 and 90 and in adult mice at days 30 and 60 after a single unilateral inner ear infusion of dose levels up to 1.3 × 10 11 vg/ear (6.5 × 10 13 vg/mL).

The highest levels of vector DNA were detected in the cochleae. Human OTOF mRNA expression in the cochleae was sustained over the study durations (27 weeks in monkeys, 60-90 days in mice), with peak expression at 6 weeks in monkeys and 4 weeks in mice, then plateauing through the final time points. Vector DNA distribution to non-otic tissues was limited, with levels at least 10-fold lower than cochlear levels in monkeys and at least 3-fold lower in mice.

The highest levels of OTARMENI vector DNA were detected in the parotid lymph node, cervical dorsal root ganglion, cervical spinal cord, and brain, while sporadic or low levels were detected in other non-otic tissues. No measurable vector DNA was detected in ovaries, and only minimal levels were detected in testes (1 of 4 mouse samples near detection limit). Human OTOF mRNA expression in non-otic tissues was restricted to neural tissues at substantially lower levels than in the cochlea.

In monkeys, human OTOF mRNA was detected only in cervical and lumbar dorsal root ganglia of one monkey at Week 7 (no detection at Week 27). In mice, human OTOF mRNA was detected in brain, cervical dorsal root ganglia, and cervical spinal cord at levels 4.9- to 96.4-fold lower than cochlear expression. No human OTOF mRNA was detected in reproductive tissues or other non-neural tissues in either species.

Clinical data Systemic distribution of vector DNA in plasma and vector DNA shedding in urine, saliva, and stool were evaluated in 15 patients administered OTARMENI at the dose of 7.2 × 10 12 vg/ear in Study DB-OTO-001. Samples were collected at baseline, at Day 1, and Week 2, 4, 6, 12, 24, and 36 following OTARMENI administration. Vector DNA was detectable in plasma, urine, and saliva at Day 1 after OTARMENI administration and was undetectable by Week 2 (the next sampling timepoint).

In stool, vector DNA was detectable through Week 6 and became undetectable by Week 12. Peak concentration was observed at Day 1 after OTARMENI administration and declined substantially thereafter.

12.6Immunogenicity The observed incidence of anti-AAV1 neutralizing antibodies and anti-OTOF antibodies is highly dependent on the sensitivity and specificity of the assays. Differences in assay methods preclude meaningful comparisons of the incidence of antibodies in the study described below with the incidence of antibodies in other studies. In the DB-OTO-001 study, patients were not excluded based on pre-existing serum anti-AAV1 neutralizing antibodies.

Immunogenicity was assessed from baseline through Week 12. A total of 12/15 (80%) patients had anti-AAV1 neutralizing antibodies at baseline (titer <1,000). All patients developed anti-AAV1 neutralizing antibody responses through Week 12 with 10/15 (67%) having titer >10,000, 3/15 (20%) having titer 1,000 to 10,000, and 2/15 (13%) having titer <1,000 responses.

A total of 1/1… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 43 words ▾

12.1Mechanism of Action Intracochlear infusion of OTARMENI results in expression of the OTOF gene primarily in inner hair cells (IHCs), which facilitates production of functional otoferlin protein and restores synaptic transmission to the auditory nerve as shown in animal studies in mice.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied OTARMENI is supplied as a single-dose vial enclosed in a sealed barrier bag. Following thaw from its frozen state, OTARMENI is a sterile, clear to slightly opalescent colorless liquid, free of visible particulates. Each vial contains a nominal titer of 3.0 × 10 13 vg/mL of OTARMENI and has an extractable volume of 0.63 mL.

The Administration Kit for use with OTARMENI is supplied separately as package 2 of 2 [ see Dosage and Administration (2.3 and 2.4) ]. Contents of Package 1 NDC Number OTARMENI 2 mL vial 61755-062-00 OTARMENI vial carton 61755-062-01 OTARMENI sealed barrier bag 61755-062-99 Contents of Package 2 NDC Number Administration Kit for use with OTARMENI One BD PrecisionGlide™ 21G, 1.5-inch sterile needle One BD 1 mL sterile syringe, Luer-Lok™ tip One BD PlastiPak™ 3 mL sterile syringe, Luer-Lok™ tip One BD Luer-Lok™ syringe tip cap One Vygon Premicath ® catheter 61755-062-11 Storage and Handling OTARMENI suspension (2 mL vial): Store and transport OTARMENI (package 1) frozen at -80°C (-112°F).

Keep the vial in the supplied carton. Thaw OTARMENI at room temperature prior to administration. If not used immediately, the unpunctured thawed vial can be stored in the refrigerator (2°C to 8°C [36°F to 46°F]) for up to 24 hours or at room temperature (up to 25°C [77°F]) for up to 8 hours [ see Dosage and Administration (2.3) ].

Do not refreeze vial once thawed. Administration Kit for use with OTARMENI: Store at room temperature in original carton separately from OTARMENI until time of use. Do not freeze.

Avoid excessive heat and direct sunlight.

📦 Storage and Handling 113 words ▾

Storage and Handling OTARMENI suspension (2 mL vial): Store and transport OTARMENI (package 1) frozen at -80°C (-112°F). Keep the vial in the supplied carton. Thaw OTARMENI at room temperature prior to administration.

If not used immediately, the unpunctured thawed vial can be stored in the refrigerator (2°C to 8°C [36°F to 46°F]) for up to 24 hours or at room temperature (up to 25°C [77°F]) for up to 8 hours [ see Dosage and Administration (2.3) ]. Do not refreeze vial once thawed. Administration Kit for use with OTARMENI: Store at room temperature in original carton separately from OTARMENI until time of use.

Do not freeze. Avoid excessive heat and direct sunlight.

📋 Description 184 words ▾

11 DESCRIPTION OTARMENI (lunsotogene parvec-cwha) is an adeno-associated virus vector-based gene therapy for intracochlear infusion. OTARMENI contains a dual adeno-associated virus serotype 1 vector (AAV1) that utilizes an engineered hair cell-specific promoter derived from regulatory elements of myosin 15 ( Myo15 ) to drive complementary DNA ( cDNA ) expression of human OTOF transcript variant 5 encoding isoform e of the otoferlin protein (OTOF). The vector is produced in human embryonic kidney cells by recombinant DNA technology.

OTARMENI is a sterile, aqueous suspension administered by intracochlear infusion. Each single-dose vial contains a nominal vector genome titer of 3.0 × 10 13 vg/mL in an extractable volume of 0.63 mL. Patients receive a total nominal dose of 7.2 × 10 12 vg per ear in a total infused volume of 0.24 mL per ear.

OTARMENI is provided in a single-dose 2 mL vial containing a clear to slightly opalescent, colorless suspension, free of visible particulates following thaw from its frozen state. The excipients include sodium phosphate (10 mM), sodium chloride (180 mM), sucrose (5% w/v), and poloxamer 188 (0.001% w/v) with a pH of 7.3.

💬 Information for Patients 202 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients or caregivers that: Prior to treatment with OTARMENI, it is recommended that patients receive the appropriate vaccinations for their age. Vaccines should be administered at least 1 month before the first corticosteroid dose and at least 1 month after the last dose [ see Dosage and Administration (2.1) ]. Before surgery, patients should consult their primary care physician and surgeon regarding vaccination status against microorganisms that cause meningitis.

Meningitis is a known risk of inner ear surgery [ see Dosage and Administration (2.1) ]. Procedural-related adverse reactions may occur following OTARMENI administration. These may include vertigo, tinnitus, cerebral spinal fluid leak, ipsilateral facial paresis, ipsilateral change in taste, meningitis, wound infection, mastoiditis, numbness around the ear, blood or fluid collection at surgical site, and labyrinthitis. [ see Warnings and Precautions (5.1) ].

Temporary vector shedding of OTARMENI occurs primarily through body waste. Practice proper hand hygiene, such as hand washing, when coming into direct contact with patient body waste. Place potentially contaminated materials that may have the patient's bodily fluids/waste in a sealable bag and dispose into regular trash.

These precautions should be followed for 2 weeks after OTARMENI infusion [ see Clinical Pharmacology (12.3) ].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Biodistribution (within the body) and Vector Shedding (excretion/secretion) OTARMENI vector DNA levels in various matrices and nonclinical tissues were determined using a qualified quantitative polymerase chain reaction (qPCR) assay. Expression of human OTOF mRNA was determined in selected nonclinical tissues. Nonclinical data Systemic distribution of vector DNA was evaluated in cynomolgus monkeys at weeks 7 and 27 after a single bilateral intracochlear infusion of dose levels up to 4.4 × 10 12 vg/ear (7.3 × 10 13 vg/mL), and in juvenile mice at days 30 and 90 and in adult mice at days 30 and 60 after a single unilateral inner ear infusion of dose levels up to 1.3 × 10 11 vg/ear (6.5 × 10 13 vg/mL).

The highest levels of vector DNA were detected in the cochleae. Human OTOF mRNA expression in the cochleae was sustained over the study durations (27 weeks in monkeys, 60-90 days in mice), with peak expression at 6 weeks in monkeys and 4 weeks in mice, then plateauing through the final time points. Vector DNA distribution to non-otic tissues was limited, with levels at least 10-fold lower than cochlear levels in monkeys and at least 3-fold lower in mice.

The highest levels of OTARMENI vector DNA were detected in the parotid lymph node, cervical dorsal root ganglion, cervical spinal cord, and brain, while sporadic or low levels were detected in other non-otic tissues. No measurable vector DNA was detected in ovaries, and only minimal levels were detected in testes (1 of 4 mouse samples near detection limit). Human OTOF mRNA expression in non-otic tissues was restricted to neural tissues at substantially lower levels than in the cochlea.

In monkeys, human OTOF mRNA was detected only in cervical and lumbar dorsal root ganglia of one monkey at Week 7 (no detection at Week 27). In mice, human OTOF mRNA was detected in brain, cervical dorsal root ganglia, and cervical spinal cord at levels 4.9- to 96.4-fold lower than cochlear expression. No human OTOF mRNA was detected in reproductive tissues or other non-neural tissues in either species.

Clinical data Systemic distribution of vector DNA in plasma and vector DNA shedding in urine, saliva, and stool were evaluated in 15 patients administered OTARMENI at the dose of 7.2 × 10 12 vg/ear in Study DB-OTO-001. Samples were collected at baseline, at Day 1, and Week 2, 4, 6, 12, 24, and 36 following OTARMENI administration. Vector DNA was detectable in plasma, urine, and saliva at Day 1 after OTARMENI administration and was undetectable by Week 2 (the next sampling timepoint).

In stool, vector DNA was detectable through Week 6 and became undetectable by Week 12. Peak concentration was observed at Day 1 after OTARMENI administration and declined substantially thereafter.

🧬 Pharmacodynamics 9 words ▾

12.2Pharmacodynamics There are no pharmacodynamics data for OTARMENI.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of OTARMENI was evaluated in an ongoing, multi-center, single-arm study (Study DB-OTO-001; NCT05788536). The study enrolled pediatric patients with molecularly confirmed OTOF gene associated profound sensorineural hearing loss (defined as >90 dB HL on pure tone audiometry averaged across 0.5, 1, 2, and 4 kHz and auditory brainstem response), evidence of outer hair cell activity by otoacoustic emissions testing, and who were considered candidates for cochlear implant. Patients with cochlear implants in the same ear to be treated with OTARMENI were excluded from the study.

A total of 24 patients (10 patients received unilateral treatment and 14 patients received bilateral treatment) received a single dose of OTARMENI at a dose of 7.2 × 10 12 vector genomes (vg) in 0.24 mL per ear. The demographic characteristics of the population (N=24): The median age was 2 years (range 10 months to 16 years), 16 patients (67%) were female, 17 patients (71%) were White, 4 patients (17%) were Asian, and 3 patients (13%) had race not reported. Eleven patients (46%) were Hispanic.

Of the 24 patients, 20 had completed efficacy assessments at 24 weeks. Among these 20 patients, five had a contralateral cochlear implant in place prior to enrollment, and two received a cochlear implant in the contralateral ear during the same surgical session for OTARMENI administration. Two patients had bilateral hearing aids before OTARMENI treatment.

The primary efficacy endpoint was the achievement of a hearing sensitivity threshold ≤70 dB HL assessed by average pure tone audiometry (i.e., average of PTA thresholds at 0.5, 1.0, 2.0, and 4.0 kHz) at Week 24 after product administration. The key secondary efficacy endpoint was the presence of auditory brainstem response (ABR) to a click (broadband sound) stimulus of ≤90 dB nHL at Week 24 after product administration. Efficacy results for Study DB-OTO-001 are presented in Table 2 below.

Table 2: Efficacy Results for Study DB-OTO-001 Endpoint N Participants Achieving Threshold/Response For patients who were treated bilaterally, the data reflect the treated ear with better average PTA/better ABR to click at Week 24. ABR: Auditory Brainstem Response; CI: Confidence Interval; PTA: Pure Tone Audiometry Primary Endpoint Achievement of a hearing sensitivity threshold of ≤70 dB HL assessed by average PTA 20 Patient without available Week 24 data (n=1) was imputed as a non-responder. n (%) 16 (80%) 95% CI 56%, 94% Key Secondary Endpoint ABR to Click at ≤90 dB nHL 20 n (%) 14 (70%) 95% CI 46%, 88% At Week 24, a total of 9/20 (45%) patients achieved an average PTA threshold ≤45 dB HL (ability to hear soft conversational speech level) and 3/20 (15%) achieved ≤25 dB HL (normal hearing level i.e., ability to hear whispers).

One patient received a cochlear implant as rescue treatment approximately 8 months after OTARMENI administration in the same ear following determination of treatment failure. Among the 20 patients, 12 patients were evaluated at Week 48 after product administration. Of these, all 9 patients who previously had a response at Week 24 and who were evaluated at Week 48 maintained their response.

One additional patient who had not initially achieved response at Week 24, achieved an average PTA threshold ≤70 dB HL by Week 48, resulting in a total of 10/12 (83%) patients who achieved an average PTA threshold ≤70 dB HL by Week 48. Eight of the 12 (67%) patients achieved an average PTA threshold ≤45 dB HL and 5 of the 12 patients (42%) achieved ≤25 dB HL by Week 48. Additionally, 9 of the 12 patients (75%) demonstrated presence of auditory brainstem response (ABR) to a click (broadband sound) stimulus of ≤90 dB nHL by Week 48.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been performed to evaluate the effects of OTARMENI on carcinogenicity, mutagenesis, or impairment of fertility.

13.2Animal Toxicology and/or Pharmacology In a 6-month study, cynomolgus monkeys (22 to 63 months old) received bilateral intracochlear administration of OTARMENI at dose levels up to 4.4 × 10 12 vg per ear. Vehicle control animals underwent the same surgical procedure, which was designed to closely mimic the intended clinical procedure. Procedure-related complications were observed across all treatment groups, including vehicle controls.

Facial nerve paralysis occurred in 6 of 36 animals (3 of 12 control animals and 3 of 24 OTARMENI-administered animals). Of the OTARMENI-administered animals that developed facial paralysis, 2 showed complete recovery by Day 3, while 1 required euthanasia on Day 3 due to severe facial paralysis and associated corneal complications. The 3 control animals with facial paralysis did not recover by their Week 7 euthanasia time point.

Permanent auditory damage was documented, including spiral ganglion cell degeneration and hair cell loss in the cochlea observed in 2 of 6 control animals and 7 of 13 OTARMENI-administered animals at Week 27. Damage was primarily limited to the injection site area in the basal turn of the cochlea, though one animal experienced more extensive cochlear damage. Hearing threshold elevations affected 55-84% of ears at high frequencies (8-16 kHz) and 21-33% of ears at low frequencies (1-4 kHz), with no recovery observed over the 6-month study duration.

Additional post-operative adverse reactions included vestibular symptoms (lasting through Day 5) such as ataxia, head tilt, and coordination problems.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 25 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been performed to evaluate the effects of OTARMENI on carcinogenicity, mutagenesis, or impairment of fertility.

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - 0.63 mL Vial Carton Barrier Bag Label NDC 61755-062-99 Rx only lunsotogene parvec-cwha Otarmeni™ 3.0 x 10 13 vg/mL Suspension for Intracochlear Infusion Single-Dose Vial, 0.63 mL per vial. Discard unused portion. Store frozen at -80°C (-112°F). Manufactured by: Regeneron Pharmaceuticals, Inc. U.S. License No. 1760 PRINCIPAL DISPLAY PANEL - 0.63 mL Vial Carton Bag Label

PRINCIPAL DISPLAY PANEL - 0.63 mL Vial Carton NDC 61755-062-01 Rx only lunsotogene parvec-cwha Otarmeni™ 3.0 x 10 13 vg/mL Suspension for Intracochlear Infusion Single-Dose Vial. Discard unused portion. Do not use if seal is broken or damaged.

Package 1 of 2 The Administration Kit for use with OTARMENI is supplied separately as package 2 of 2. OTARMENI must be administered with the Administration Kit provided. Single-Dose Vial, 0.63 mL per vial REGENERON PRINCIPAL DISPLAY PANEL - 0.63 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 0.63 mL Vial Label NDC 61755-062-00 Rx only lunsotogene parvec-cwha Otarmeni™ 3.0 x 10 13 vg/mL Suspension for Intracochlear Infusion Single-Dose Vial, 0.63 mL per vial. Discard unused portion. PRINCIPAL DISPLAY PANEL - 0.63 mL Vial Label

PRINCIPAL DISPLAY PANEL - Device Kit Carton NDC 61755-062-11 Rx only Administration Kit FOR USE ONLY WITH lunsotogene parvec-cwha Otarmeni™ For Intracochlear Infusion Only Dosage: See enclosed prescribing information. Contents of Administration Kit: One BD PrecisionGlide™ 21G, 1.5-inch sterile needle One BD 1 mL sterile syringe, Luer-Lok™ tip One BD PlastiPak™ 3 mL sterile syringe, Luer-Lok™ tip One BD Luer-Lok™ syringe tip cap One Vygon Premicath ® Catheter Package 2 of 2 OTARMENI vial is supplied separately in package 1 of 2.

Caution: – Store at room temperature in original carton separately from OTARMENI until time of use. Do not freeze. – Do not use if seal is broken or damaged. – Single use only. Do not reuse. – Avoid excessive heat and direct sunlight.

NOTE: – This Administration Kit has no components made of natural latex rubber. – Individual devices are provided in separate sterile packaging. – Use the expiration date on this carton. REGENERON PRINCIPAL DISPLAY PANEL - Device Kit Carton

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

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