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

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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