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Lumvoa veligrotug 50 mg/mL Injection — NDC 85166-0001-01 package photo
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Lumvoa veligrotug 50 mg/mL Injection — NDC 85166-001-01 (Billing 85166-0001-01)

by Viridian Therapeutics, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of Lumvoa veligrotug 50 mg/mL Injection from Viridian Therapeutics, Inc., marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 85166-0001-01
🏷️ FDA NDC (as labeled) 85166-001-01 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 Jul 24, 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 85166-001-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
85166 labeler · 001 product · 01 package
Package marketed since
Jun 26, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0385166001017
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85166-001-01
Product NDC 85166-001
11-digit billing NDC 85166000101
NCPDP billing unit ML — per mL (volume)
RxCUI 2746009, 2746016
UNII Z9U2SS9ZC8
UPC 0385166001017
Application # BLA761530
SPL Set ID 11bc286a-5411-45af-af3f-69ad38efb610
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-26
Route INTRAVENOUS
Dosage form INJECTION
Substance VELIGROTUG
Quick answers
  • RxCUI (RxNorm): 2746009
Why two NDCs? The FDA registers this code as 85166-001-01 — 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 → 85166-0001-01. 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

Veligrotug-vvze injection is used treat thyroid eye disease(TED; Graves' eye disease; a disorder in which the immune system causes inflammation and swelling behind the eye). Veligrotug-vvze is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain protein in the body that causes inflammation in the eye.

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
85166-0001-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 2026-06-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lumvoa 50 mg/mLthis 85166-0001-01 Viridian 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
Jun 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.

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

  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • UNII AE28F7PNPL
    Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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

LabelerViridian Therapeutics, Inc.
FDA applicationBLA761530 (BLA)
Labeler code85166
First marketedJun 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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 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 49 words ▾

1 INDICATIONS AND USAGE LUMVOA is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. LUMVOA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION 10 mg/kg every three weeks for a total of 5 infusions ( 2.1 ) Administer LUMVOA by intravenous infusion over 30 to 45 minutes ( 2.3 ) See full prescribing information for dose preparation and administration instructions ( 2.2 , 2.3 )

2.1Recommended Dosage The recommended dosage of LUMVOA is 10 mg/kg administered by intravenous infusion every three weeks for a total of 5 infusions.

2.2Dose Preparation Step 1: Calculate the dose (mg) and determine the number of vials needed for the 10 mg/kg dosage based on patient weight. Each LUMVOA vial contains 500 mg of veligrotug antibody. Step 2: Use a 250 mL 0.9% Sodium Chloride infusion bag to prepare the diluted solution.

To maintain a constant volume in the infusion bag, use a sterile syringe and needle to remove the volume equivalent to the amount of the LUMVOA solution to be placed into the infusion bag. Discard the withdrawn volume of 0.9% Sodium Chloride. Step 3: Withdraw the required volume from the LUMVOA vial(s) based on the patient's weight (in kg) and transfer into the intravenous bag containing 0.9% Sodium Chloride Solution.

Mix the diluted solution by gentle inversion to avoid foaming. Do not shake. LUMVOA does not contain any preservative.

The storage time of the diluted solution in the infusion bag containing 0.9% Sodium Chloride Injection is 4 hours at room temperature 20°C to 25°C (68°F to 77°F) or up to 72 hours under refrigerated conditions at 2°C to 8°C (36°F to 46°F), protected from light. If refrigerated prior to administration, allow the diluted solution to reach room temperature prior to infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

The diluted solution should be a colorless, clear liquid, and free of visible particles. Discard the solution if any particulate matter or discoloration are observed. Do not freeze the diluted solution.

Discard vial(s) and all unused contents. LUMVOA compatibility with the infusion solution has been demonstrated in the following intravenous administration materials: Intravenous (IV) Bag: polyvinyl chloride (PVC), ethyl vinyl acetate (EVA), polypropylene-styrene-ethylene-butylene-styrene (PP-SEBS), and ethylene-propylene copolymer (polyolefin (PO)). Inline 0.2- or 0.22-micron filters: polyethersulfone solution filter (PES) and polyvinylidene fluoride air filter (PVDF).

Infusion sets: polyvinyl chloride/bis (2-ethylhexyl) phthalate (PVC/DEHP), polyurethane (PUR), and polyethylene (without DEHP).

2.3Administration Instructions Administer the diluted solution intravenously over 45 minutes for the first infusion. If well tolerated, subsequent infusions can be administered over a minimum of 30 minutes. If not well tolerated, the minimum time for subsequent infusions should remain at 45 minutes. Do not administer LUMVOA as an intravenous push or bolus. LUMVOA should not be infused concomitantly with other agents.

💊 Dosage Forms and Strengths 35 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 500 mg/10 mL (50 mg/mL) yellowish to brown, slightly opalescent solution in a single-dose vial. Injection: 500 mg/10 mL (50 mg/mL) solution in a single-dose vial ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Infusion Reactions : If an infusion reaction occurs, interrupt or slow the rate of infusion and use appropriate medical management ( 5.1 ) Inflammatory Bowel Disease (IBD) : Monitor patients for signs and symptoms of disease, including patients without a history of IBD; discontinue LUMVOA if IBD is suspected ( 5.2 ) Hyperglycemia : Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with LUMVOA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving LUMVOA.

Continue monitoring after treatment for patients who experience hyperglycemia while on LUMVOA ( 5.3 ) Hearing Impairment including Hearing Loss : LUMVOA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patient's hearing before, during, and after treatment with LUMVOA and consider the benefit-risk of treatment with patients ( 5.4 )

5.1Infusion Reactions LUMVOA may cause infusion reactions. Infusion reactions have been reported in approximately 9% of patients treated with LUMVOA. Signs and symptoms of infusion-related reactions include transient increases in blood pressure, fever, chills, headache, and fatigue.

Infusion reactions may occur during or soon after an infusion. Reported infusion reactions are usually mild or moderate in severity and can usually be successfully managed with corticosteroids, antihistamines, and antipyretics. In patients who experience an infusion reaction, consideration should be given to standard premedication and/or administering infusions at a slower infusion rate.

5.2Inflammatory Bowel Disease LUMVOA may cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients receiving insulin-like growth factor-1 receptor inhibitors without a prior diagnosis of IBD. Monitor patients for signs and symptoms of IBD, including patients without a history of IBD. If IBD is suspected, discontinue use of LUMVOA.

5.3Hyperglycemia Hyperglycemia or increased blood glucose may occur in patients treated with LUMVOA. In clinical trials, 12% of patients, of whom one half had pre-existing diabetes or impaired glucose tolerance, experienced hyperglycemia. Hyperglycemic events should be controlled with medications for glycemic control, if necessary.

Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with LUMVOA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving LUMVOA. Continue monitoring after treatment for patients who experience hyperglycemia while on LUMVOA.

5.4Hearing Impairment Including Hearing Loss LUMVOA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients' hearing before, during, and after treatment with LUMVOA and consider the benefit-risk of treatment with patients.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [ see Warnings and Precautions ( 5.1 ) ] Inflammatory Bowel Disease [ see Warnings and Precautions ( 5.2 ) ] Hyperglycemia [ see Warnings and Precautions ( 5.3 ) ] Hearing Impairment [ see Warnings and Precautions ( 5.4 ) ] Most common adverse reactions (incidence of 5% or more) are muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, blood creatine phosphokinase increased, dry skin, and hypertension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viridian Therapeutics, Inc. at 1-866-321-VRDN (1-866-321-8736) 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 of LUMVOA was evaluated in two randomized, double-masked, placebo-controlled clinical studies (Study 1 [NCT05176639] and Study 2 [NCT06021054]) consisting of 113 patients with active thyroid eye disease (75 received LUMVOA and 38 received placebo) and 188 patients with chronic thyroid eye disease (125 received LUMVOA and 63 received placebo).

Patients were treated with LUMVOA 10 mg/kg or placebo given as an intravenous infusion every 3 weeks for a total of 5 infusions. The majority of patients completed 5 infusions (94% of LUMVOA patients and 99% of placebo patients). The most common adverse reactions (≥5%) that occurred at greater incidence in the LUMVOA group than in the control group during the treatment period of Studies 1 and 2 are summarized in Table 1 .

In addition, menstrual disorders (amenorrhea, menstruation irregular, dysmenorrhea, menstruation delayed, intermenstrual bleeding, and menstrual disorder) were reported in approximately 29% (24/82) of menstruating women treated with LUMVOA compared to 6% (2/33) of patients treated with placebo in the clinical trials. Table 1: Adverse Reactions Occurring in 5% or More of Patients Treated with LUMVOA and Greater Incidence than Placebo in Study 1 and Study 2 Adverse Reactions LUMVOA N=200 N (%) Placebo N=101 N (%) 1 Hearing impairment includes tinnitus, hypoacusis, deafness, and autophony.

2 Hyperglycemia includes blood glucose increased, glucose tolerance impaired, glycosylated hemoglobin increased, diabetes mellitus, glucose urine present, and impaired fasting glucose. 3 Fatigue includes asthenia. 4 Ear discomfort includes ear feels clogged or blocked, ear plugging, sensation of ear pressure, and ear popping.

Muscle spasms 79 (40%) 7 (7%) Headache 34 (17%) 14 (14%) Hearing impairment 1 29 (15%) 6 (6%) Hyperglycemia 2 25 (13%) 5 (5%) Fatigue 3 25 (13%) 11 (11%) Diarrhea 22 (11%) 7 (7%) Ear discomfort 4 19 (10%) 3 (3%) Infusion-related reaction 18 (9%) 2 (2%) Nausea 15 (8%) 6 (6%) Nasopharyngitis 14 (7%) 1 (1%) Blood creatine phosphokinase increased 12 (6%) 1 (1%) Dry skin 12 (6%) 2 (2%) Hypertension 11 (6%) 5 (5%) During the follow-up period, the most common adverse reactions in patients treated with LUMVOA were alopecia and onychoclasis (5%).

Immune thrombocytopenia was also reported in one patient.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Females of Reproductive Potential: Appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months following the last dose of LUMVOA ( 8.3 )

8.1Pregnancy Risk Summary Because inhibiting insulin-like growth factor-1 receptor (IGF-1R) signaling impacts embryonic development and placental development and function, LUMVOA may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There is insufficient data with LUMVOA use in pregnant women to inform any drug associated risks for adverse developmental outcomes. Animal reproductive and developmental toxicity studies have not been conducted with LUMVOA.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. LUMVOA should not be used during pregnancy, and appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months after the last dose of LUMVOA. Women of childbearing potential should have a pregnancy test performed by their doctor before starting treatment with LUMVOA.

If the patient becomes pregnant during treatment, LUMVOA should be discontinued and the patient advised of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. 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 is no information regarding the presence of LUMVOA in human milk, the effects on the breast-fed infant or the effects on milk production.

8.3Females and Males of Reproductive Potential Contraception Females Because inhibiting IGF-1R signaling impacts normal embryonic development and placental development and function, LUMVOA may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception prior to initiation, during treatment with LUMVOA and for 6 months after the last dose of LUMVOA.

8.4Pediatric Use The safety and effectiveness of LUMVOA have not been established in pediatric patients.

8.5Geriatric Use Of the 301 patients in Study 1 and Study 2, 12% were 65 years of age or older, with a similar proportion of patients 65 years of age or older between treatment groups. No overall differences in safety or effectiveness of LUMVOA have been observed between patients 65 years of age or older and younger adult patients.

🤰 Pregnancy 194 words ▾

8.1Pregnancy Risk Summary Because inhibiting insulin-like growth factor-1 receptor (IGF-1R) signaling impacts embryonic development and placental development and function, LUMVOA may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There is insufficient data with LUMVOA use in pregnant women to inform any drug associated risks for adverse developmental outcomes. Animal reproductive and developmental toxicity studies have not been conducted with LUMVOA.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. LUMVOA should not be used during pregnancy, and appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months after the last dose of LUMVOA. Women of childbearing potential should have a pregnancy test performed by their doctor before starting treatment with LUMVOA.

If the patient becomes pregnant during treatment, LUMVOA should be discontinued and the patient advised of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. 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 16 words ▾

8.4Pediatric Use The safety and effectiveness of LUMVOA have not been established in pediatric patients.

🧓 Geriatric Use 60 words ▾

8.5Geriatric Use Of the 301 patients in Study 1 and Study 2, 12% were 65 years of age or older, with a similar proportion of patients 65 years of age or older between treatment groups. No overall differences in safety or effectiveness of LUMVOA have been observed between patients 65 years of age or older and younger adult patients.

🆘 Overdosage 13 words ▾

10 OVERDOSAGE No information is available for patients who have received an overdosage.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Veligrotug-vvze's mechanism of action in patients with thyroid eye disease has not been fully characterized. Veligrotug-vvze is a humanized IgG1 monoclonal antibody that binds to IGF-1R and inhibits IGF-1R signaling by blocking ligand-induced receptor autophosphorylation.

12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted with veligrotug-vvze.

12.3Pharmacokinetics The pharmacokinetics (PK) of veligrotug-vvze were described by a two-compartment population PK model based on data from 298 patients with thyroid eye disease receiving 10 mg/kg LUMVOA every 3 weeks in 4 clinical trials. Following this dose regimen, the geometric mean estimates for steady-state area under the concentration curve (AUC), peak (C max ), and trough (C trough ) concentrations of veligrotug-vvze were 3450 mcg∙day/mL, 363 mcg/mL, and 97.8 mcg/mL, respectively. Distribution The population PK estimated mean central and peripheral volume of distribution of veligrotug-vvze were

2.80 L and

2.50L, respectively. Elimination The population PK estimated mean (% relative standard error) linear clearance of veligrotug-vvze was 0.216 (2.7) L/day with a corresponding half-life of approximately 18 days. Metabolism Metabolism of veligrotug-vvze has not been fully characterized.

However, veligrotug-vvze is expected to undergo metabolism via proteolysis. Specific Populations No clinically meaningful differences in the pharmacokinetics of veligrotug-vvze were observed following administration of LUMVOA based on patient's age (20 - 79 years), sex (216 female and 82 male), race/ethnicity (224 White, 22 Black, and 13 Asian), or weight (41 - 161 kg). Neither renal nor hepatic impairment is expected to influence the pharmacokinetics of veligrotug-vvze.

Drug Interaction Studies No studies evaluating the drug interaction potential of LUMVOA have been conducted.

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of LUMVOA or of other veligrotug products. In controlled clinical studies with veligrotug, ADA sampling was conducted during the 15-week treatment period, as well as during the post treatment follow-up period 12 weeks after the final infusion.

Two hundred and ninety (290) of 361 patients (80.3%) had evaluable samples for ADA assessment, in which treatment emergent anti-veligrotug antibodies were detected in 20% (58/290) of patients. In general, there was no apparent correlation of anti-veligrotug antibody development with changes in the pharmacokinetics, safety, and/or effectiveness of veligrotug.

🧬 Mechanism of Action 39 words ▾

12.1Mechanism of Action Veligrotug-vvze's mechanism of action in patients with thyroid eye disease has not been fully characterized. Veligrotug-vvze is a humanized IgG1 monoclonal antibody that binds to IGF-1R and inhibits IGF-1R signaling by blocking ligand-induced receptor autophosphorylation.

📦 How Supplied / Storage and Handling 60 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LUMVOA (veligrotug-vvze) injection is a sterile, preservative-free, yellowish to brown, slightly opalescent solution available as follows: Carton containing one 500 mg/10 mL (50 mg/mL) single-dose vial NDC 85166-001-01 Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.

📦 Storage and Handling 25 words ▾

Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.

📋 Description 101 words ▾

11 DESCRIPTION Veligrotug-vvze, an insulin-like growth factor-1 receptor inhibitor (IGF-1R), is a humanized IgG1ϰ monoclonal antibody produced in Chinese hamster ovary (CHO-K1) cells. It has a molecular weight of approximately 150 kilodaltons. LUMVOA (veligrotug-vvze) injection is supplied as a sterile, preservative-free, yellowish to brown, slightly opalescent solution, and free of visible particles, for intravenous infusion.

Each single-dose vial contains 500 mg of veligrotug-vvze, histidine (6.50 mg), L-histidine hydrochloride monohydrate (33.1 mg), methionine (14.9 mg), polysorbate 80 (2.0 mg), sucrose (800 mg), and Water for Injection (quantity sufficient to 10 mL). The final concentration is 50 mg/mL with a pH of 5.5.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Embryo-Fetal Toxicity Advise females of reproductive potential that LUMVOA may cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Educate and counsel females of reproductive potential about the need to use effective contraception prior to initiation of, during treatment with LUMVOA and for 6 months after the last dose of LUMVOA. Infusion Reactions Advise patients that LUMVOA may cause infusion reactions that can occur during or soon after an infusion.

Instruct patients to recognize the signs and symptoms of infusion reactions and to contact their healthcare provider immediately for signs or symptoms of potential infusion-related reactions. Inflammatory Bowel Disease Advise patients on the risk of inflammatory bowel disease (IBD), including patients with or without a prior diagnosis of IBD. Advise patients to seek medical advice immediately if they experience diarrhea, with or without blood, or rectal bleeding, associated with abdominal pain or cramping/colic, fecal urgency, tenesmus or incontinence.

Hyperglycemia Advise patients on the risk of hyperglycemia and, if diabetic, discuss with healthcare provider to adjust glycemic control measures including medications as appropriate. Encourage compliance with glycemic control. Hearing Impairment Including Hearing Loss Advise patients that LUMVOA may cause severe hearing impairment including hearing loss, which in some cases may be permanent.

Instruct patients to contact their healthcare provider if they experience any signs or symptoms of hearing impairment or any changes in hearing. Manufactured by: Viridian Therapeutics, Inc. 221 Crescent Street, Suite 103A Waltham, MA 02453 U.S.

License No. 2377

🧬 Pharmacokinetics 211 words ▾

12.3Pharmacokinetics The pharmacokinetics (PK) of veligrotug-vvze were described by a two-compartment population PK model based on data from 298 patients with thyroid eye disease receiving 10 mg/kg LUMVOA every 3 weeks in 4 clinical trials. Following this dose regimen, the geometric mean estimates for steady-state area under the concentration curve (AUC), peak (C max ), and trough (C trough ) concentrations of veligrotug-vvze were 3450 mcg∙day/mL, 363 mcg/mL, and 97.8 mcg/mL, respectively. Distribution The population PK estimated mean central and peripheral volume of distribution of veligrotug-vvze were

2.80 L and

2.50L, respectively. Elimination The population PK estimated mean (% relative standard error) linear clearance of veligrotug-vvze was 0.216 (2.7) L/day with a corresponding half-life of approximately 18 days. Metabolism Metabolism of veligrotug-vvze has not been fully characterized.

However, veligrotug-vvze is expected to undergo metabolism via proteolysis. Specific Populations No clinically meaningful differences in the pharmacokinetics of veligrotug-vvze were observed following administration of LUMVOA based on patient's age (20 - 79 years), sex (216 female and 82 male), race/ethnicity (224 White, 22 Black, and 13 Asian), or weight (41 - 161 kg). Neither renal nor hepatic impairment is expected to influence the pharmacokinetics of veligrotug-vvze.

Drug Interaction Studies No studies evaluating the drug interaction potential of LUMVOA have been conducted.

🧬 Pharmacodynamics 11 words ▾

12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted with veligrotug-vvze.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES LUMVOA was evaluated in 301 patients across 2 randomized, double-masked, placebo-controlled studies: active thyroid eye disease (Study 1: NCT05176639) and chronic thyroid eye disease (Study 2: NCT06021054). Patients were randomized to receive LUMVOA or placebo in a 2:1 ratio. Patients were given intravenous infusions of LUMVOA 10 mg/kg every 3 weeks for a total of 5 infusions.

Patients in Study 1 had a clinical diagnosis of thyroid eye disease with onset within 15 months and a clinical activity score of 3 or more. Patients in Study 2 had a clinical diagnosis of thyroid eye disease with onset greater than 15 months and any clinical activity score (0-7). Prior orbital decompression surgery was permitted in either study if surgery was limited to bone.

Patients with abnormal baseline audiometry Pure Tone Average (PTA) assessment or history of significant (as determined by the investigator) ear pathology, relevant ear surgery, or hearing loss were excluded. Patients with biopsy proven or clinical evidence of inflammatory bowel disease (IBD) were also excluded. In Study 1, 75 patients with active thyroid eye disease were randomized to LUMVOA and 38 patients were randomized to placebo.

The median age was 50 years (range 23 to 79 years), 77% were female, 62% were White, 6% were Black or African-American, 8% were Asian and 13% identified as Other. At baseline, 17% of patients were current users of tobacco. Proptosis ranged from 13.7 to 33.3 mm and 76 patients (67%) had diplopia at baseline.

In Study 2, 125 patients with chronic thyroid eye disease were randomized to LUMVOA and 63 patients were randomized to placebo. The median age was 52 years (range 20 to 77 years), 75% were female, 76% were White, 10% were Black or African-American, 3% were Asian and 4% identified as Other. At baseline, 26% of patients were current users of tobacco.

Proptosis ranged from 14.1 to 35.0 mm and 102 patients (54%) had diplopia at baseline. Clinical activity scores ranged from 0 to 7 with 66 patients (35%) having a clinical activity score of 0 or 1 at baseline. The proptosis responder rate at Week 15 was defined as the percentage of patients with ≥2 mm reduction in proptosis in the study eye from baseline, without deterioration in proptosis (≥2 mm increase) in the non-study eye.

Additional evaluations included signs and symptoms of thyroid eye disease including diplopia, retrobulbar pain, gaze evoked orbital pain, eyelid swelling, eyelid erythema, conjunctival redness, chemosis, inflammation, clinical activity score, and assessments of quality of life (functional vision and patient appearance). The proptosis results at Week 15 as measured by exophthalmometer in Studies 1 and 2 are provided in Table 2 . Similar proptosis results were observed when measured by magnetic resonance imaging (MRI)/computed tomography (CT).

Table 2: Efficacy Results in Patients with Active Thyroid Eye Disease (Study 1) or Chronic Thyroid Eye Disease (Study 2) Study 1 (Active Thyroid Eye Disease) Study 2 (Chronic Thyroid Eye Disease) 1 Proptosis responder rate (PRR) results via exophthalmometer were analyzed based on a generalized estimating equation (GEE) model of baseline through Week 15 data. 2 Results were obtained from a mixed model for repeated measures (MMRM) with an unstructured covariance matrix and included treatment, baseline value, visit, treatment by visit, and visit by baseline value interaction as fixed effects.

A change from Baseline of 0 was imputed at the first post-Baseline visit for any subject without a post-Baseline value. LUMVOA (N=75) Placebo (N=38) Difference (95% CI) p-value LUMVOA (N=125) Placebo (N=63) Difference (95% CI) p-value Proptosis responder rate at Week 15 – exophthalmometer, % 1 70% 5% 65% (52, 78) <0.01 57% 8% 49% (38, 60) <0.01 Proptosis (mm) average change from baseline at Week 15 – exophthalmometer, LS Mean (SE) 2 -2.9 (0.2) -0.5 (0.2) -2.4 (-3.0, -1.8) <0.01 -2.4 (0.2) -0.5 (0.2) -1.9 (-2.4, -1.4) <0.01 In Studies 1 and… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 81 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of LUMVOA has not been evaluated in long-term animal studies. Mutagenesis The genotoxic potential of LUMVOA has not been evaluated. Impairment of Fertility Dedicated fertility studies have not been performed with LUMVOA.

In the repeat-dose toxicology studies in sexually mature male and female cynomolgus monkeys, no effects on the reproductive system were observed at exposure higher (7-fold) than the human exposure (AUC) at the maximum recommended human dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 78 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of LUMVOA has not been evaluated in long-term animal studies. Mutagenesis The genotoxic potential of LUMVOA has not been evaluated. Impairment of Fertility Dedicated fertility studies have not been performed with LUMVOA.

In the repeat-dose toxicology studies in sexually mature male and female cynomolgus monkeys, no effects on the reproductive system were observed at exposure higher (7-fold) than the human exposure (AUC) at the maximum recommended human dose.

📄 Package Label / Principal Display Panel 47 words ▾

Principal Display Panel - 500 mg/10 mL Carton Label NDC 85166-001-01 LUMVOA™ (veligrotug-vvze) Injection 500 mg/10 mL (50 mg/mL) For Intravenous Use Only Dilute prior to use. One 10 mL Single-dose vial. Discard unused portion. Rx Only VIRIDIAN Principal Display Panel - 500 mg/10 mL Carton Label

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

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← 85165-0253-01 · SICHUAN 85173-0001-01 · Shenzhen →
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