Overview
- Viridian announced Monday that the U.S. Food and Drug Administration approved Lumvoa (veligrotug‑vvze) for the treatment of thyroid eye disease and labeled it for both active and chronic forms.
- Approval rested on two pivotal Phase 3 trials, THRIVE and THRIVE‑2, that met primary and secondary endpoints and showed rapid benefit with measurable proptosis reduction by about three weeks and greater gains by week 15.
- Trial data reported higher rates of diplopia response and complete diplopia resolution with Lumvoa versus placebo, with reported complete resolution rates of about 54% versus 12% in active disease and 32% versus 14% in chronic disease.
- Lumvoa targets the insulin‑like growth factor 1 receptor like the existing drug Tepezza but differs in dosing and delivery, using five infusions over 12 weeks with shorter infusion times compared with Tepezza’s eight‑infusion regimen.
- Viridian is launching Lumvoa immediately and rolling out ViridianCares for insurance navigation and financial assistance, while the label lists warnings for infusion reactions, inflammatory bowel disease, hyperglycemia, and hearing changes and payor coverage and long‑term real‑world safety will shape patient access.