MONDAY, July 6, 2026 (HealthDay News) -- The U.S. Food and Drug Administration has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED).
Lumvoa received Breakthrough Therapy Designation and was approved by the FDA under Priority Review. It is now the first approved treatment for TED with labeling that includes data for both active and chronic disease.
The approval was supported by results from the THRIVE (active TED) and THRIVE-2 (chronic TED) pivotal phase 3 clinical trials, which consistently demonstrated significant and clinically meaningful improvements in key signs and symptoms of TED at 15 weeks. Patients enrolled in both trials received a 12-week course of Lumvoa, with clinical benefit seen as early as three weeks. Statistically significant effects were seen for diplopia response and complete resolution in active and chronic TED.
The most common adverse reactions reported (incidence of 5 percent or more) were muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin, and hypertension.
"It's encouraging to see a new treatment for the full spectrum of the disease, with data showing rapid onset of proptosis reduction as well as improvements in diplopia," Michael Yen, M.D., from the Baylor College of Medicine in Houston and an investigator in the THRIVE program, said in a statement. "This is an exciting new option for physicians to offer their TED patients."
Approval of Lumvoa was granted to Viridian Therapeutics.
