Priority Review for Roche Enspryng sBLA

FDA has granted priority review for a Roche sBLA for Enspryng (satralizumab) to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), an autoimmune disease with no approved treatments. A company statement says FDA is expected to make a decision on the sBLA by 1/10/2027.

Roche says acceptance of the filing was based on positive results from the Phase 3 METEOROID study that showed that Enspryng provided consistent, clinically meaningful improvements for people living with MOGAD.

Enspryng, developed by Roche Group member Chugai, is described as a humanized monoclonal antibody that targets interleukin-6, said to be a key chemical messenger involved in the body's inflammatory response, receptor activity.

The drug has an FDA orphan drug designation for MOGAD and for neuromyelitis optica spectrum disorder. FDA granted priority review for an sBLA to treat thyroid eye disease. A decision on that sBLA is expected in October.