FDA Approves New TED Drug for Active and Chronic Phases

Lumvoa is the first approved product for TED to show a statistically significant effect with both diplopia response and complete resolution of diplopia in active and chronic disease. Thyroid eye disease (TED) has the potential to be a sight-threatening and debilitating condition that can present with a wide variety of clinical signs and symptoms. It is characterized by an active phase of autoimmune-driven orbital and soft tissue inflammation that lasts roughly six to 18 months in total, followed by an inactive phase of chronic tissue fibrosis. Newly developed and more targeted treatments are gaining popularity due to their potential for better clinical outcomes and safety profiles.Earlier this week, Viridian Therapeutics announced the FDA approval of Lumvoa (veligrotug-vvze), a full antagonist of IGF-1R and the first therapeutic option for TED that shows a statistically significant effect on both diplopia response and complete resolution of diplopia in active and chronic disease.Lumvoa was approved by the FDA under priority review based on the THRIVE (active TED) and THRIVE-2 (chronic TED) Phase III clinical trials. Both THRIVE and THRIVE-2 met their respective primary and all secondary endpoints, 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 (10mg/kg dose, five intravenous infusions) and showed reductions in proptosis as early as three weeks. These improvements were accompanied by corresponding clinically meaningful improvements in quality of life, according to Viridian.The company plans to launch Lumvoa immediately, and physicians can prescribe it shortly. In a press release, Viridian said it has worked closely with payers, healthcare providers and patient advocates to support broad access to Lumvoa.For more information, go to www.lumvoa.com.