一次情報の記録
決定級EMA 意見
Omeros Receives CHMP Negative Opinion on Narsoplimab MAA for TA-TMA After Re-Examination
CHMPは再審査の後、TA-TMAにおけるnarsoplimabのMAAに対して否定的意見を発出しました。臨時専門家グループがさらなる患者レベルデータのレビューを推奨したにもかかわらずです。これは2026年6月の当初の否定的意見に続くもので、2025年12月のYARTEMLEAのFDA承認とは対照的です。欧州ではTA-TMAに対する承認済み治療法は存在しません。
主要事実
出典の抜粋
Omeros Corporation Receives CHMP Negative Opinion Following Re-Examination of European Marketing Authorization Application for Narsoplimab in TA-TMA Omeros Corporation Receives CHMP Negative Opinion Following Re-Examination of European Marketing Authorization Application for Narsoplimab in TA-TMA Omeros Corporation Receives CHMP Negative Opinion Following Re-Examination of European Marketing Authorization Application for Narsoplimab in TA-TMA Omeros Corporation (Nasdaq: OMER) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the company’s marketing authorization application (MAA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (T