USFDAJun 29, 2026, 06:06 AM
Viridian Therapeutics Receives FDA Approval for Lumvoa for Thyroid Eye Disease
AI Summary
Viridian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED), regardless of activity or duration. Lumvoa is the first approved treatment for TED with labeling that includes data for both active and chronic TED, and Viridian plans to launch it immediately. The approval is supported by positive results from the THRIVE and THRIVE-2 pivotal Phase 3 clinical trials, which demonstrated rapid and significant improvements in TED symptoms.
Key Highlights
- FDA approved Lumvoa (veligrotug-vvze) for thyroid eye disease (TED).
- Lumvoa is the first approved TED treatment with data for active and chronic TED.
- Viridian Therapeutics plans an immediate launch of Lumvoa.
- Lumvoa demonstrated rapid, consistent, and durable reductions in TED signs/symptoms.
- Showed statistically significant effect in diplopia response and complete resolution.
- Subcutaneous elegrobart BLA submission is on track for Q1 2027.
- Company will host a conference call and webcast on June 29 at 8:00 a.m. ET.
Price Impact
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