Viridian Therapeutics' Lumvoa (veligrotug-vvze) has been approved by the U.S. FDA for the treatment of thyroid eye disease (TED), marking the company's first FDA‑approved product and commercial launch in this indication.
Lumvoa is the first approved TED treatment with a label covering both active and chronic disease, based on the pivotal phase 3 THRIVE (active TED) and THRIVE‑2 (chronic TED) trials, which met all primary and secondary endpoints with statistically significant and clinically meaningful improvements in key signs and symptoms, including proptosis and diplopia.
The FDA approved Lumvoa under Priority Review, ahead of the June 30, 2026 PDUFA target date; Viridian is launching the drug immediately, positioning it as a direct competitor to Amgen's Tepezza (teprotumumab) in the TED market.
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Viridian Therapeutics Announces U.S. FDA Approval and Launch of ...
Viridian Therapeutics Says FDA Approves Lumvoa to Treat Thyroid ...
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Viridian Therapeutics宣布Lumvoa获美国食品药品监督管理局批准用于治疗甲状腺眼病
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비리디안테라퓨틱스, FDA 최초 승인 갑상선안병증 치료제 Lumvoa 즉시 출시
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Viridian Therapeutics高管称其甲状腺眼病药物Lumvoa五次输注疗程定价与安进Tepezza八次输注疗程大致相当 来自电话会议
FDA accepts Viridian's veligrotug BLA for TED
[PDF] BLA 761263/S-006 ACCELERATED APPROVAL Genentech, Inc ...