FDA grants priority review to Roche’s Enspryng for MOGAD treatment

Reuters2026/09/10 05:00

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FDA granted Priority Review for Roche’s sBLA seeking Enspryng approval to treat MOGAD, a rare autoimmune central nervous system disease.
Decision expected by Jan. 10, 2027; Enspryng would be the first disease-modifying therapy approved for MOGAD.
Phase III METEOROID showed a 68% relapse-risk reduction versus placebo; 87% remained relapse-free at 48 weeks.
EMA validated the MOGAD application; European Commission decision expected in Q3 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Roche Holding AG published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202609100100OMX_____CNEWS_EN_GNW1001261908_en) on September 10, 2026, and is solely responsible for the information contained therein.

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FDA grants priority review to Roche’s Enspryng for MOGAD treatment

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