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
韻律表示，歐洲藥品管理局的CHMP通過了積美芙(IMCIVREE)的陽性意見，建議批准上市；歐洲委員會決策預計在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.
歐洲藥品管理局（EMA）人類藥品委員會（CHMP）已通過肯定意見，建議IMCIVREE（setmelanotide）的市場授權範圍包括2歲以上不滿6歲的因Bardet Biedl綜合徵（BBS）或前促黑素細胞生成抑制物（POMC）、前蛋白酶亞基裂解酶/可溶酰氨酰酶型1（PCSK1）或瘦素受體（LEPR）缺陷所致肥胖的兒童。