FDA Priority Review Puts Satralizumab on Track as First MOGAD Drug

The FDA has granted priority review for satralizumab, positioning it as the first potential disease-modifying therapy for MOGAD, with a parallel filing initiated with the EMA targeting a 2027 decision. The METEOROID trial enrolled patients aged 12 and older and concluded with robust data after 28 adjudicated relapses, enhancing the evidence for approval.

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