FDA 对 Roche 的 Enspryng 治疗 MOGAD 授予优先审评

Roche Announces U.S. FDA Grants Priority Review for Enspryng for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

AI 导读

Chugai 表示，Roche 宣布 FDA 已受理 Enspryng（satralizumab）用于成人和青少年 MOGAD 的申请并授予优先审评，预计 2027 年 1 月 10 日前作出决定。EMA 已受理该药用于成人 MOGAD 的上市申请，欧盟委员会预计 2027 年三季度决定。

研究关注

可跟踪 Enspryng 在 MOGAD 的注册节奏：FDA 优先审评与 EMA 申报受理并行，关注 2027 年两个审评节点。

正文 · 原文

TOKYO, September 10, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Roche announced that the U.S. Food and Drug Administration (FDA) has accepted Roche’s application for Enspryng^® (satralizumab) for the treatment of adult and adolescent patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and granted Priority Review for the application. The FDA is expected to make its decision by 10 January 2027.

In addition, the European Medicines Agency (EMA) has validated the Marketing Authorisation Application for Enspryng for the treatment of adult patients with MOGAD in Europe. A decision by the European Commission is expected in the third quarter of 2027.

Please refer to the link below for details of the media release:

U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments

https://www.roche.com/media/releases/med-cor-2026-09-10

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