Enspryng (satralizumab) for MOG antibody-associated disease (MOGAD)
The FDA is expected to decide on Enspryng for MOG antibody-associated disease (MOGAD) by January 10, 2027, under a sBLA from Genentech (Roche).
What is being decided
Genentech (Roche) has a sBLA under FDA review for Enspryng (satralizumab) in MOG antibody-associated disease (MOGAD). Priority review. Would be the first approved treatment for MOGAD, a rare autoimmune disease that attacks the optic nerves, spinal cord and brain. In the Phase 3 METEOROID trial, Enspryng cut the risk of relapse by 68%, with 87% of treated patients relapse-free at 48 weeks versus 67% on placebo. Already approved for NMOSD.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Frequently asked questions
When will the FDA decide on Enspryng?
The FDA's target decision date (PDUFA date) for Enspryng in MOG antibody-associated disease (MOGAD) is January 10, 2027, disclosed by Genentech (Roche). The agency can act before this date and occasionally runs past it.
What is Enspryng being reviewed for?
Genentech (Roche) submitted a sBLA for Enspryng in MOG antibody-associated disease (MOGAD). Priority review. Would be the first approved treatment for MOGAD, a rare autoimmune disease that attacks the optic nerves, spinal cord and brain. In the Phase 3 METEOROID trial, Enspryng cut the risk of relapse by 68%, with 87% of treated patients relapse-free at 48 weeks versus 67% on placebo. Already approved for NMOSD.
What happens after the Enspryng decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Genentech press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.