FDA Approves Viridian Therapeutics' Lumvoa for Thyroid Eye Disease, Creating Competition with Amgen's Tepezza

The U.S. FDA approved Viridian Therapeutics' Lumvoa (veligrotug-vvze) on June 26, 2026, for thyroid eye disease, breaking Amgen's Tepezza monopoly. Supported by the THRIVE trials, Lumvoa is the first approved therapy labeled for both active and chronic forms of the disease. Viridian is launching the drug immediately alongside its ViridianCares support program, while advancing a subcutaneous formulation, elegrobart, toward a Q1 2027 regulatory submission.

Lumvoa FDA approval

• ▪Lumvoa is the first approved treatment for thyroid eye disease with labeling that includes data for both active and chronic forms of the disease
• ▪The U.S. Food and Drug Administration approved Viridian Therapeutics' drug Lumvoa (veligrotug-vvze) on June 26, 2026, for the treatment of thyroid eye disease
• ▪The FDA approved Lumvoa under Priority Review and previously granted the drug Breakthrough Therapy Designation

THRIVE trial efficacy results

• ▪In the THRIVE trials, Lumvoa demonstrated reductions in proptosis as early as three weeks and showed a statistically significant effect in diplopia response
• ▪The approval of Lumvoa was supported by the THRIVE and THRIVE-2 phase 3 clinical trials, which met their primary and secondary endpoints at week 15

Lumvoa commercial launch

• ▪Viridian Therapeutics will host a conference call and webcast on Monday, June 29, 2026, at 8:00 a.m. ET to discuss the FDA approval of Lumvoa
• ▪Viridian Therapeutics plans to launch Lumvoa immediately, making the drug available for physicians to prescribe starting June 27, 2026

Patient support program

• ▪Viridian Therapeutics established ViridianCares, a patient support program providing patient access liaisons, insurance coverage support, and financial assistance
• ▪The ViridianCares patient support program can be reached by calling the dedicated phone number 866-822-7371

Lumvoa safety profile

• ▪Lumvoa may cause infusion reactions, which were reported in approximately 9% of patients treated with the drug in clinical evaluations
• ▪In clinical trials, 12% of patients treated with Lumvoa experienced hyperglycemia, with half of those patients having preexisting diabetes or impaired glucose tolerance
• ▪Lumvoa may cause severe and potentially permanent hearing impairment, including hearing loss, requiring hearing assessments before, during, and after treatment

Subcutaneous elegrobart BLA timeline

• ▪Viridian Therapeutics is on track to submit a biologics license application for its subcutaneous therapy elegrobart in the first quarter of 2027
• ▪Elegrobart is a late-stage investigational subcutaneous therapy designed to address unmet needs and improve patient convenience in thyroid eye disease