BASEL, Switzerland — September 10, 2026
Roche announced that the U.S. Food and Drug Administration (FDA) granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). If approved, Enspryng could become the first and only disease-modifying therapy for MOGAD, a rare autoimmune disorder of the central nervous system for which there are currently no approved treatments. The regulatory filing is supported by positive Phase III METEOROID results showing that Enspryng reduced the risk of MOGAD relapse by 68% compared with placebo. The FDA is expected to issue its decision by January 10, 2027. The milestone adds another regulatory opportunity for Enspryng, which also received FDA Priority Review for thyroid eye disease earlier in 2026.
METEOROID Data Support Significant Relapse Reduction
The Phase III METEOROID study provides the clinical foundation for Roche’s MOGAD regulatory submission, meeting its primary endpoint of time to first relapse during the double-blind treatment period. Enspryng reduced the risk of a new relapse by 68% versus placebo (p=0.0025), with 87% of patients remaining relapse-free at 48 weeks, compared with 67% in the placebo group. The treatment also demonstrated significant improvements across key secondary measures, including annualised relapse rate, MRI lesion activity and rescue therapy use. These findings are particularly relevant in MOGAD because recurrent attacks can affect the optic nerves, brain and spinal cord and may result in permanent neurological damage, vision loss and disability. Roche said the METEOROID safety profile remained consistent with more than a decade of Enspryng clinical trial and post-approval experience in neuromyelitis optica spectrum disorder (NMOSD).
Enspryng Targets IL-6 Signalling in Autoimmune Disease
Enspryng is a humanised monoclonal antibody targeting the interleukin-6 (IL-6) receptor, a pathway involved in inflammatory immune responses. Developed by Chugai, a Roche Group company, the therapy incorporates recycling antibody technology intended to support sustained IL-6 inhibition through repeated binding to the IL-6 receptor. Enspryng is already approved in approximately 90 countries for NMOSD, including the United States and European Union, and Roche reports experience in more than 10,000 patients. The company is leveraging this established clinical and regulatory foundation as it expands Enspryng into additional neurological autoimmune and inflammatory conditions. The MOGAD program therefore represents both a potential new indication and an extension of Roche’s broader strategy to apply IL-6 pathway inhibition across diseases with significant unmet medical need.
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Roche Expands Enspryng Neurology Franchise
The MOGAD filing strengthens Roche’s broader neurology development strategy while adding another potential regulatory milestone for Enspryng. The European Medicines Agency has validated Roche’s application for MOGAD, with a European Commission decision expected in the third quarter of 2027. Roche is also investigating Enspryng in autoimmune encephalitis and thyroid eye disease, with the FDA’s decision on the thyroid eye disease sBLA expected in October 2026. If approved for MOGAD, Enspryng would potentially establish a new disease-modifying treatment option in a condition characterised by unpredictable and potentially disabling relapses. With strong Phase III relapse-reduction data, FDA Priority Review and European regulatory validation, Roche is positioning Enspryng for expansion beyond NMOSD and toward a broader neurological autoimmune disease franchise.
Source: Roche,,press release
