Roche (SIX: RO, ROP; OTCQX: RHHBY) said on September 10 that the U.S. Food and Drug Administration has granted Priority Review to a supplemental Biologics License Application for Enspryng (satralizumab) to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), a rare autoimmune condition with no approved therapies.
The filing was supported by positive results from the Phase III METEOROID study, which met its primary endpoint of time from randomisation to first MOGAD relapse. Enspryng reduced the risk of a new relapse by 68% compared with placebo (p=0.0025). At 48 weeks, 87% of patients on Enspryng remained relapse-free versus 67% on placebo. The drug also showed significant improvements across secondary measures, including annualised relapse rate, MRI lesion activity and rescue therapy use.
The FDA is expected to issue a decision by January 10, 2027. In Europe, the European Medicines Agency has validated the application, with a European Commission decision anticipated in the third quarter of 2027.
This marks the second Priority Review designation for Enspryng, after the FDA granted the same status in June 2026 for its use in thyroid eye disease (TED), with an approval decision expected in October.
Levi Garraway, MD, PhD, Roche's chief medical officer, called MOGAD "unpredictable and debilitating," noting that each relapse can cause lasting neurological damage and that there are currently no approved treatments. He said Enspryng has the potential to transform care by significantly reducing serious attacks and decreasing reliance on high-dose steroids and immunosuppressants.
Enspryng is a humanised monoclonal antibody targeting the interleukin-6 (IL-6) receptor, developed using novel recycling antibody technology that allows sustained IL-6 inhibition. It is already approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the U.S. and E.U., with a safety profile established across more than 10,000 patients.
MOGAD is a rare autoimmune disease of the central nervous system, with an estimated prevalence of 0.51 to 3.42 per 100,000 people. Attacks can affect the optic nerves, brain and spinal cord, potentially leading to vision loss, confusion, muscle weakness and disability. Relapsing MOGAD involves unpredictable worsening of neurological symptoms that may not fully resolve, resulting in accumulating permanent damage.
Roche is investigating Enspryng in additional neurological autoimmune and inflammatory conditions, including anti-NMDA receptor autoimmune encephalitis and leucine-rich glioma-inactivated 1 autoimmune encephalitis, where the drug holds orphan drug designation in both the U.S. and E.U.
