FDA grants Priority Review for Roche's Enspryng for MOGAD, an autoimmune disease with ...

The FDA has granted Priority Review to Roche's Enspryng for the treatment of MOGAD, a rare autoimmune central nervous system disease with no approved treatments. The Phase III METEOROID study showed Enspryng reduced relapse risk by 68%, with FDA decision expected by January 2027 and EMA decision anticipated in Q3 2027.

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