Roche’s Enspryng (satralizumab), a treatment for a rare autoimmune disease, has been given FDA Priority Review to a supplemental Biologics License Application (sBLA).
Myelin oligodendrocyte glycoprotein antibody-associated disease (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.
“MOGAD 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, 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.”
MOGAD is estimated to impact 0.51 to 3.42 per 100,000 people, affecting all ages, with the symptoms that 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.
The METEOROID study, presented at the American Academy of Neurology (AAN) Annual Meeting in April 2026, showed that Enspryng significantly reduced the risk of a new relapse by 68% compared to placebo, 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 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.