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GSKのエフィモスフェルミンがMASH治療薬としてFDAとEMAの指定を受ける

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-- GSK(グラクソ・スミスクライン)は月曜日、同社の肝疾患治療薬エフィモスフェルミンが、代謝機能障害関連脂肪性肝炎(MASH)の治療薬として、米国食品医薬品局(FDA)から画期的治療薬指定(Breakthrough Therapy Designation)を、欧州医薬品庁(EMA)から優先医薬品指定(Priority Medicines Designation)を取得したと発表した。 FDAの指定は医薬品の開発・審査を迅速化することを目的としており、EMAの指定は科学的・規制上の支援を提供するものである。 これらの指定は、中等度から進行期の肝線維症および肝硬変患者を対象とした第2相試験データに基づいている。このデータでは、プラセボと比較して肝線維症の改善とMASHの寛解が認められた。同社は、この治療薬は概ね良好な安全性プロファイルを示したと述べている。 同社は、肝線維症を伴うMASH患者を対象とした第3相試験を今年中に開始する予定であると発表した。

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