Roche’s Enspryng has moved a step closer to becoming a treatment for myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).

 

This, after the US Food and Drug Administration granted Priority Review to the global pharma powerhouse's supplemental Biologics License Application.

 

The FDA’s action follows positive Phase III METEOROID trial results, in which Enspryng demonstrated clinically meaningful benefits for people living with MOGAD. The regulator is expected to decide on approval by 10 January 2027.

 

The FDA decision marks the second Priority Review for Enspryng, following a review granted for thyroid eye disease in June 2026.

 

Roche also said the European Medicines Agency has validated its application for Enspryng in MOGAD. A decision from the European Commission is expected in the third quarter of 2027.

 

“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."

 

The Phase III METEOROID study, presented at the American Academy of Neurology Annual Meeting in April 2026, met its primary endpoint, measuring the time from randomisation to the first MOGAD relapse during the double-blind treatment period.

 

Roche said Enspryng reduced the risk of a new relapse by 68% compared with placebo, with the result reaching statistical significance.

 

At 48 weeks, 87% of patients treated with Enspryng remained relapse-free, compared with 67% of those receiving placebo.

 

The drug also showed significant improvements across key secondary measures, including annualised relapse rates, MRI lesion activity and the use of rescue therapy.

 

Roche said the safety profile observed in METEOROID was consistent with more than a decade of clinical trial and post-approval experience with Enspryng in neuromyelitis optica spectrum disorder (NMOSD).

 

MOGAD is a rare autoimmune disease in which the immune system mistakenly attacks parts of the central nervous system. The disease can trigger sudden attacks affecting the optic nerves, brain and spinal cord.