Viridian Therapeutics Lands Its First FDA Approval With Lumvoa for Thyroid Eye Disease
The FDA approved Viridian Therapeutics' Lumvoa for thyroid eye disease across active and chronic stages, marking the company's first commercial product following its pivotal THRIVE Phase 3 program.
Viridian Therapeutics crossed the line from clinical-stage hopeful to commercial company with its first FDA approval.
Viridian is a Nasdaq-listed biotech focused on thyroid eye disease, or TED, a serious autoimmune condition that can cause bulging eyes, double vision and, in severe cases, vision loss. Its lead asset targets the IGF-1R pathway that drives the disease.
On June 26 the FDA approved Lumvoa (veligrotug-vvze), a full IGF-1R antagonist, for the treatment of TED regardless of disease activity or duration. The approval, granted under Priority Review, makes Lumvoa Viridian's first commercial product and, according to the company, the first TED therapy whose label includes data across both active and chronic disease. It was supported by the pivotal THRIVE and THRIVE-2 Phase 3 trials, and is administered as five intravenous infusions over roughly 12 weeks, a shorter course than the long-standing standard of care. Viridian said it launched the product immediately.
TED already has an entrenched competitor, and converting a first approval into durable sales is a costly, unproven undertaking.
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