FDA Grants Priority Review to Roche's Enspryng for MOGAD, With Decision Due January 2027
核心洞察
The FDA has granted Priority Review to a supplemental Biologics License Application for Roche's Enspryng (satralizumab) in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD (搜索)), with a decision expected by January 10, 2027.
The filing is supported by the Phase III METEOROID study, in which Enspryng reduced the risk of a new MOGAD (搜索) relapse by 68% versus placebo (p=0.0025).
At 48 weeks, 87% of Enspryng-treated patients remained relapse-free compared with 67% in the placebo arm, with improvements also seen in annualized relapse rate, MRI lesion activity and rescue therapy use.
Roche announced on 10 September 2026 that the U.S. Food and Drug Administration 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 (搜索)). The FDA is expected to make a decision on approval by 10 January 2027. This marks the second FDA Priority Review for Enspryng, following the one granted for thyroid eye disease (搜索) (TED) in June 2026.
If approved, Enspryng would become the first and only disease-modifying therapy for MOGAD (搜索), a rare autoimmune disorder of the central nervous system for which there are currently no approved treatment options.
METEOROID Trial Results
The filing acceptance is based on positive results from the Phase III METEOROID study, which met its primary endpoint of time from randomisation to the first MOGAD (搜索) relapse during the double-blind treatment period. Enspryng significantly reduced the risk of a new relapse by 68% compared with placebo (p=0.0025), with 87% of Enspryng-treated patients remaining relapse-free at 48 weeks compared with 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 METEOROID data were presented at the American Academy of Neurology (AAN) Annual Meeting in April 2026.
The safety profile observed 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 (搜索) (NMOSD).
"MOGAD (搜索) can be unpredictable and debilitating, with each relapse carrying the potential for lasting neurological damage, yet there are currently no approved treatments," said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. "Enspryng has the potential to transform care for people living with MOGAD, significantly reducing serious attacks and decreasing the reliance on high-dose steroids and immunosuppressants."
Mechanism and Prior Approvals
Enspryng was developed by Chugai (搜索), 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. The therapy 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 (搜索), 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 NMOSD, including in the U.S. and E.U., with a well-established safety profile in over 10,000 patients.
Disease Burden in MOGAD
MOGAD (搜索) is a rare autoimmune disease in which 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. The disease preferentially affects the optic nerves but can also affect the brain and spinal cord, and its prevalence is estimated to range from 0.51 to 3.42 per 100,000 people.
MOGAD (搜索) can affect people of all ages, and 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.
Regulatory and Development Outlook
Beyond the U.S., the European Medicines Agency (搜索) has validated the MOGAD (搜索) application for Enspryng, with a European Commission decision expected in the third quarter of 2027.
Enspryng holds orphan drug designation in the U.S. and E.U. for NMOSD and MOGAD (搜索), and in the U.S. for anti-NMDA receptor autoimmune encephalitis (搜索) (anti-NMDAR AIE) and leucine-rich glioma-inactivated 1 autoimmune encephalitis (LGI1 AIE). Roche is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 signalling, including autoimmune encephalitis (AIE) and thyroid eye disease (搜索) (TED).
For TED, the FDA granted Priority Review of the Enspryng sBLA in June 2026, with an approval decision expected in October 2026. A potential approval would make Enspryng the first at-home subcutaneous disease-modifying standard of care for TED.
Neurology is a major focus of research and development at Roche, which is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, NMOSD, Alzheimer's disease, Huntington's disease, Parkinson's disease and Duchenne muscular dystrophy.