Viridian Therapeutics gets FDA approval for Lumvoa; immediate U.S. launch planned

Viridian Therapeutics announced FDA approval of Lumvoa (veligrotug-vvze) for thyroid eye disease and plans an immediate U.S. launch.

Key Highlights:

• FDA approved Lumvoa for treatment of thyroid eye disease regardless of activity or duration.
• Lumvoa is first approved TED therapy with labeling and positive data for both active and chronic disease.
• Pivotal THRIVE and THRIVE-2 trials met primary and all secondary endpoints; benefits seen as early as 3 weeks.
• Viridian plans to launch Lumvoa immediately and will support access via the ViridianCares patient program.
• Safety notes include infusion reactions (~9%), hyperglycemia (12% in trials), potential IBD exacerbation, and hearing impairment.

Original SEC Filing:

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