The Enspryng FDA review has been accelerated after the U.S. regulator granted Priority Review to an application seeking approval of the drug for myelin oligodendrocyte glycoprotein antibody-associated disease, or MOGAD. Enspryng is developed by Genentech, a member of Roche (OTCQX: RHHBY).
The supplemental biologics license application is supported by the Phase 3 METEOROID study. Roche said the trial showed consistent, clinically meaningful improvements for people with MOGAD, including a 68% reduction in the risk of relapses. The company expects an FDA decision by January 10, 2027.
Enspryng FDA Review Could Address an Unmet Need
MOGAD is a rare autoimmune condition affecting the central nervous system, with attacks capable of damaging the optic nerves, spinal cord or brain. Roche said there are currently no approved treatments specifically for the disease. If cleared for this indication, Enspryng could become the first disease-modifying therapy available to these patients.
The European Medicines Agency has also validated Roche’s application for Enspryng in MOGAD. A decision from the European Commission is expected in the third quarter of 2027, according to the company.
Priority Review shortens the regulator’s intended review timetable but does not indicate that approval is certain. The outcome of the Enspryng FDA review will depend on the agency’s assessment of efficacy, safety and manufacturing information in the full application. Enspryng is already approved in multiple markets for neuromyelitis optica spectrum disorder.
