Rhythm Says European Medicines Agency's CHMP Adopted Positive Opinion Recommending Marketing Authorization For IMCIVREE; European Commission Decision Anticipated In H2 Of 2024
Rhythm Says European Medicines Agency's CHMP Adopted Positive Opinion Recommending Marketing Authorization For IMCIVREE; European Commission Decision Anticipated In H2 Of 2024
韵律表示，欧洲药品管理局的CHMP通过了积美芙(IMCIVREE)的阳性意见，建议批准上市；欧洲委员会决策预计在2024年下半年。
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization for IMCIVREE (setmelanotide) include children between 2 and younger than 6 years old with obesity due to Bardet Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency.
欧洲药品管理局（EMA）人用药品委员会（CHMP）已通过一项积极意见，建议IMCIVREE（setmelanotide）的上市许可包括因Bardet Biedl综合征（BBS）或促阿片皮质素（POMC）、促蛋白转化酶枯草蛋白/可欣1型（PCSK1）而肥胖的2至6岁儿童激素受体 (LEPR) 缺乏。