Roche's Enspryng Gets FDA Priority Review For MOGAD
(RTTNews) - Roche Holding AG (RHHBY), on Thursday announced that the U.S.FDA has granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease.
The FDA is expected to make a decision by January 10, 2027.
Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is a rare autoimmune disease of the central nervous system in which the immune system attacks the optic nerves, brain or spinal cord.
The disease can cause unpredictable relapses, potentially resulting in vision loss, neurological damage and disability. There are currently no approved treatments specifically for MOGAD.
Enspryng (satralizumab) is a humanized monoclonal antibody that is designed to target the interleukin-6 (IL-6) receptor, helping suppress inflammatory signaling involved in the disease.
The filing is supported by the Phase 3 METEOROID study, which showed that Enspryng reduced the risk of MOGAD relapse by 68% versus placebo. At 48 weeks, 87% of patients receiving the drug remained relapse-free, compared to 67% on placebo.
The safety profile of the drug in the Phase 3 METEOROID trial was consistent with its established safety profile from more than a decade of clinical trial and post-approval experience in NMOSD. Roche said Enspryng also improved annualized relapse rates, MRI lesions activity and rescue therapy use.
If approved, the drug would become the first and only disease-modifying therapy for MOGAD.
The drug candidate has Orphan Drug designation in the U.S. and European Union (E.U) for neuromyelitis optica spectrum disorder (NMOSD) and MOGAD, and in the U.S., for anti-NMDA receptor autoimmune encephalitis (anti-NMDAR AIE) and leucine-rich glioma-inactivated 1 autoimmune encephalitis (LGI1 AIE). It is already approved in 90 countries for NMOSD and has been used in more than 9,000 patients worldwide.
Additionally, Roche confirmed that the European Medicines Agency has validated the MOGAD application, with a European Commission decision expected in the third quarter of 2027.
RHHBY closed Thursday's trade at $53.38, down 1.28%.
