The U.S. Food and Drug Administration has approved Lumvoa (veligrotug-vvze) to treat thyroid eye disease (TED), making it the first approved therapy for the condition with labeling that includes data in both active and chronic disease, according to a company press release.
The company said it will launch the treatment immediately, with physicians able to begin prescribing it the day after the approval announcement.
The approval was granted under the FDA’s Priority Review program and was supported by results from the Phase 3 THRIVE trial in active TED and THRIVE-2 trial in chronic TED. Both studies met their primary and all secondary endpoints, demonstrating statistically significant and clinically meaningful improvements across key signs and symptoms of TED at week 15.
Patients in both trials received a 12-week course of Lumvoa. The treatment demonstrated reductions in proptosis as early as 3 weeks and is the first approved TED therapy to show statistically significant improvements in both diplopia response and complete diplopia resolution in patients with active and chronic disease.
Read the full press release here.
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