Roche’s Enspryng Wins FDA Priority Review for MOGAD After 68% Relapse-Risk Reduction

The U.S. Food and Drug Administration has accepted Roche’s supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) in MOGAD and granted Priority Review. The FDA is expected to decide on the application by January 10, 2027.

MOGAD is a rare autoimmune disorder of the central nervous system (CNS) in which antibodies targeting myelin oligodendrocyte glycoprotein (MOG) contribute to inflammatory attacks involving the optic nerves, brain and spinal cord. Relapses can cause vision loss, weakness, sensory impairment, cognitive symptoms and other neurological disability, with some patients experiencing incomplete recovery and permanent damage.

There are currently no approved disease-modifying treatments for MOGAD, leaving patients dependent largely on immunosuppressive approaches and therapies used to manage acute attacks or prevent recurrence.

METEOROID Demonstrated Significant Relapse Protection

The regulatory filing is supported by the Phase III METEOROID study (NCT05271409), which met its primary endpoint of time from randomisation to the first MOGAD relapse during the double-blind treatment period.

Satralizumab reduced the risk of a new relapse by 68% versus placebo (p=0.0025). At 48 weeks, 87% of patients receiving Enspryng remained relapse-free, compared with 67% of those receiving placebo.

The treatment also produced significant improvements across key secondary measures, including annualised relapse rate, MRI lesion activity and use of rescue therapy.

These findings suggest that inhibiting the IL-6 pathway can suppress the inflammatory activity underlying recurrent MOGAD attacks and potentially reduce the neurological burden associated with relapse.

The safety profile observed in METEOROID was consistent with Enspryng’s established safety experience from more than a decade of clinical development and post-approval use in neuromyelitis optica spectrum disorder (NMOSD).

IL-6 Blockade Extends Enspryng’s Neurological Reach

Satralizumab is a humanised monoclonal antibody that targets the interleukin-6 (IL-6) receptor. IL-6 signalling plays an important role in inflammatory immune responses, making the pathway a relevant therapeutic target across several autoimmune neurological disorders.

Enspryng uses antibody recycling technology that supports repeated engagement with the IL-6 receptor and sustained pathway inhibition.

The drug is already approved in approximately 90 countries for NMOSD, providing a substantial clinical and safety database. Roche is also developing satralizumab in autoimmune encephalitis and thyroid eye disease.

U.S. and European Regulatory Decisions Ahead

Roche’s Chief Medical Officer, Levi Garraway, said MOGAD remains unpredictable and potentially debilitating, with repeated attacks capable of causing lasting neurological damage. He highlighted the potential for satralizumab to reduce serious attacks while decreasing reliance on high-dose steroids and immunosuppressive treatment.

The European Medicines Agency has also validated Roche’s MOGAD application. The European Commission is expected to issue a decision in the third quarter of 2027.

Enspryng already holds orphan drug designation for MOGAD in both the U.S. and EU. If regulators approve the application, satralizumab would establish a new disease-modifying treatment option in a condition where no approved therapy currently exists.

 Reference

U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments, Roche, 10 September 2026