Announcement • Jun 29
Viridian Therapeutics Receives U.S. FDA Approval and Launches Lumvoa for the Treatment of Thyroid Eye Disease
Viridian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED). Lumvoa is the first approved treatment for thyroid eye disease (TED) with labeling that includes data for both active and chronic TED. In two pivotal phase 3 clinical trials, Lumvoa treatment showed rapid, consistent, and durable reductions of the key signs and symptoms of both active and chronic TED. Lumvoa is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution of diplopia in active and chronic disease. Viridian plans to launch Lumvoa immediately, a pivotal milestone as the company’s first commercial product in TED with subcutaneous elegrobart on track for a biologics license application (BLA) submission in First Quarter 2027. 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 of the 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 three 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. Lumvoa was granted Breakthrough Therapy Designation and Priority Review by the FDA. Lumvoa is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. Lumvoa may cause infusion reactions. Infusion reactions have been reported in approximately 9% of patients treated with Lumvoa. Signs and symptoms of infusion-related reactions include transient increases in blood pressure, fever, chills, headache, and fatigue. Infusion reactions may occur during or soon after an infusion. Reported infusion reactions are usually mild or moderate in severity and can usually be successfully managed with corticosteroids, antihistamines, and antipyretics. In patients who experience an infusion reaction, consideration should be given to standard premedication and/or administering infusions at a slower infusion rate. Lumvoa may cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients receiving insulin-like growth factor-1 receptor inhibitors without a prior diagnosis of IBD. Monitor patients for signs and symptoms of IBD, including patients without a history of IBD. If IBD is suspected, discontinue use of Lumvoa. Hyperglycemia or increased blood glucose may occur in patients treated with Lumvoa. In clinical trials, 12% of patients, of whom one-half had preexisting diabetes or impaired glucose tolerance, experienced hyperglycemia. Hyperglycemic events should be controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with Lumvoa. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving Lumvoa. Continue monitoring after treatment for patients who experience hyperglycemia while on Lumvoa. Lumvoa may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with Lumvoa and consider the benefit-risk of treatment with patients. Most common adverse reactions (incidence of 5% or more) are muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, blood creatine phosphokinase increased, dry skin, and hypertension. Appropriate forms of contraception should be implemented prior to initiation, during treatment, and for 6 months following the last dose of Lumvoa. Lumvoa (500 mg) is an injection for infusion. Lumvoa is administered over 12 weeks as five intravenous infusions, each given every three weeks.
