Roche (SIX: RO; OTCQX: RHHBY) announced a US FDA Priority Review award for a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The FDA is expected to issue a decision by 10 January 2027. No approved therapy currently exists for MOGAD.

The filing is supported by the Phase III METEOROID study, which met its primary endpoint of time from randomization to first MOGAD relapse during the double-blind treatment period. Satralizumab reduced the risk of relapse by 68% versus placebo (p=0.0025), with 87% of treated patients relapse-free at 48 weeks compared with 67% in the placebo arm. Key secondary endpoints were also statistically significant: the annualized relapse rate (ARR) fell by 66% (p=0.0030), the annualized rate of active MRI lesions across the optic nerves, brain, and spinal cord declined by 79% (p=0.0026), and the proportion of patients requiring rescue therapy was 73% lower with satralizumab than placebo (p=0.0024). The safety profile was consistent with more than a decade of Enspryng data in neuromyelitis optica spectrum disorder (NMOSD); no new signals were identified.

Enspryng has been approved in approximately 90 countries for AQP4 antibody-positive NMOSD since its initial US FDA approval in August 2020, based on the Phase III SAkuraStar and SAkuraSky trials. The METEOROID data, presented at the American Academy of Neurology Annual Meeting in April 2026, constitute the regulatory package now under Priority Review — a designation that sets a six-month review clock for conditions lacking approved therapies.

Separately, the European Medicines Agency (EMA) has validated an application for Enspryng in MOGAD, with a European Commission decision expected in Q3 2027. Roche also received Priority Review for Enspryng in thyroid eye disease (TED) in June 2026, making MOGAD the molecule's second concurrent Priority Review filing.

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