Rhythm Pharmaceuticals：FDA批准IMCIVREE用于获得性下丘脑性肥胖

FDA于2026年3月19日批准IMCIVREE（setmelanotide）用于获得性下丘脑性肥胖。批准后六周内收到超过150份患者起始表格。欧洲委员会也授予同一适应症的上市许可。

关键事实

申报时间: 2026年5月5日 11:48
事件: FDA 批准
方向: 积极
公司: RYTMRhythm
资产: setmelanotide
来源: SEC 8-K
可信度: 有来源
处方医师: 约 300 名
获批日期: 2026-03-19
患者起始表格: >400 份

来源摘录

EX-99.1 2 q12026earningspr_draft.htm EX-99.1 Document Rhythm Pharmaceuticals Reports First Quarter 2026 Financial Results and Business Update -- IMCIVREE ® (setmelanotide) launched in the U.S. for acquired hypothalamic obesity; more than 150 patient start forms received in the first six weeks following FDA approval on March 19, 2026 -- -- First quarter 2026 net product revenue from global sales of IMCIVREE of $60.1 million -- -- IMCIVREE granted Marketing Authorization by European Commission for the treatment of obesity and control of hunger in patients with acquired hypothalamic obesity -- -- Japanese regulatory review of New Drug Application for setmelanotide to treat acquired hypothalamic obesity underway -- -- Management to host conference call today at 8:00 a.m. ET -- BOSTON,

SEC 8-K