Announcement • Sep 10

Roche Receives U.S. FDA Priority Review for Enspryng for MOGAD

Roche announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The filing acceptance is based on positive results from the Phase III METEOROID study, which showed that Enspryng provided consistent, clinically meaningful improvements for people living with MOGAD. The FDA is expected to make a decision on approval in MOGAD by 10 January 2027. Additionally, the European Medicines Agency (EMA) has validated the application for Enspryng for MOGAD in Europe. The decision by the European Commission is expected in the third quarter of 2027. The METEOROID study, presented at the American Academy of Neurology (AAN) Annual Meeting in April 2026, met its primary endpoint of time from randomisation to the first MOGAD relapse during the double-blind treatment period. Enspryng significantly reduced the risk of a new relapse by 68% compared to placebo (p=0.0025), with 87% of Enspryng-treated patients remaining relapse-free at 48 weeks compared to 67% in the placebo arm. Enspryng also provided significant improvements across key secondary measures, including annualised relapse rate, MRI lesion activity and rescue therapy use. The safety profile in the METEOROID study was consistent with data from more than a decade of Enspryng clinical trial and post-approval experience in neuromyelitis optica spectrum disorder (NMOSD). MOGAD is a rare autoimmune disease where the immune system mistakenly attacks parts of the central nervous system. It can cause sudden attacks on the optic nerves, brain and spinal cord, which can lead to vision loss, confusion, muscle weakness and disability. Enspryng was developed by Chugai, a member of the Roche Group, and is a humanised monoclonal antibody that targets interleukin-6 (IL-6), a key chemical messenger involved in the body's inflammatory response, receptor activity. Enspryng was designed using novel recycling antibody technology which, compared to conventional technology, allows for sustained IL-6 inhibition by binding strongly and repeatedly to the IL-6 receptor enabling rapid and sustained suppression of inflammatory pathways. Enspryng is the first and only IL-6 inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the U.S. and E.U., with a well-established safety profile in over 10,000 patients. Enspryng has orphan drug designation in the U.S. and E.U. for 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). The FDA granted Priority Review of the Enspryng supplemental Biologics License Application (sBLA) for TED in June 2026 with an approval decision expected in October 2026. MOGAD is a rare autoimmune disease of the central nervous system (CNS) that preferentially affects the optic nerves but can also affect the brain and spinal cord. The prevalence of MOGAD is estimated to range from 0.51 to 3.42 per 100,000 people. The disease can affect people of all ages, and the symptoms are often severe and debilitating, including loss of vision, pain, fatigue, numbness, bladder/bowel or erectile dysfunction, impaired ambulation and cognitive dysfunction. Relapsing MOGAD is characterised by multiple, unpredictable attacks of worsening neurological symptoms. Symptoms may not fully resolve after an attack, leading to accumulating, permanent, neurological damage, vision loss and disability. Currently, there are no approved treatment options available for MOGAD.

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