Viridian Therapeutics announced in a press release that the US Food and Drug Administration (FDA) has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED).

The company said it plans to launch Lumvoa immediately, and physicians can prescribe Lumvoa beginning June 27. The company said it has worked closely with payers, health care providers, and patient advocates to support broad access to Lumvoa. As part of this commitment, Viridian has created ViridianCares, a comprehensive patient support program that provides dedicated patient access liaisons, insurance coverage support and benefit verification, and financial assistance programs for eligible patients, to help patients and caregivers navigate the treatment journey and receive therapy as prescribed. 

According to Viridian, Lumvoa was approved by the FDA under Priority Review and supported by the THRIVE (active TED) and THRIVE-2 (chronic TED) pivotal phase 3 clinical trials. Lumvoa is a full antagonist of IGF-1R and the first approved treatment for TED with labeling that includes data for both active and chronic TED. Both the THRIVE and THRIVE-2 clinical trials met their respective primary and all secondary endpoints, consistently demonstrating statistically significant and clinically meaningful improvements at week 15 across all key signs and symptoms of TED.

Across both clinical trials, patients received a 12-week course of Lumvoa designed to reduce the burden of treatment. Lumvoa demonstrated a rapid onset of clinical benefit, with reductions in proptosis observed as early as 3 weeks. Lumvoa is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution in active and chronic TED, and was granted Breakthrough Therapy Designation and Priority Review by the FDA. For the full Prescribing Information for Lumvoa, click here. OM