FDA approves Viridian's Lumvoa for thyroid eye disease

Viridian Therapeutics announced that the U.S. Food and Drug Administration has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED).¹ The approval covers the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration.¹

The company said Lumvoa was approved under Priority Review and was supported by the THRIVE (active TED) and THRIVE-2 (chronic TED) pivotal phase 3 clinical trials.¹ According to Viridian, both studies met their primary and all secondary endpoints, with statistically significant and what the company called clinically meaningful improvements at week 15 across the key signs and symptoms of TED.¹ The company also said Lumvoa showed a rapid onset of clinical benefit, with reductions in proptosis observed as early as three weeks.¹

Viridian describes Lumvoa as an IGF-1R full antagonist and says it is the first TED treatment whose label includes data spanning both active and chronic disease, and the first approved TED product to show a statistically significant effect in both diplopia response and complete diplopia resolution across active and chronic disease.¹ The drug is dosed as five intravenous infusions over 12 weeks, each given every three weeks.¹

The FDA label lists warnings for infusion reactions, reported in approximately 9% of patients treated with Lumvoa¹, inflammatory bowel disease exacerbation, hyperglycemia (seen in 12% of patients, of whom one-half had preexisting diabetes or impaired glucose tolerance¹), and potential hearing impairment.

Viridian said it will launch Lumvoa immediately and is also developing elegrobart, a subcutaneous therapy intended to further address TED needs and improve patient convenience,¹ with a BLA submission planned for Q1 2027.