Roche Secures FDA Priority Review for Enspryng, Targeting Untreated Rare Disease

The FDA granted Priority Review for Roche’s supplemental Biologics License Application for Enspryng.

The treatment targets myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).

MOGAD is a rare central nervous system autoimmune disease with no currently approved treatments.

Data from the Phase III METEOROID study supports the application.

Enspryng reduced the risk of relapse by 68% compared to a placebo.

The FDA expects to issue an approval decision by January 10, 2027.

The European Medicines Agency also validated the application for Enspryng.

A European regulatory decision is anticipated in the third quarter of 2027.