Enspryng (satralizumab) for MOG antibody-associated disease (MOGAD)
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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.
About the drug
Enspryng: humanized recycling antibody against the interleukin-6 receptor, binding both the soluble and membrane-bound forms to block IL-6 signaling. Our full Enspryng profile covers how it works, side effects in plain language, and its trial history.
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.
We'll email you when the decision is public, with what it means in plain language, and when new trials open for MOG Antibody-Associated Disease. Unsubscribe anytime.
Our coverage
Frequently asked questions
When will the FDA decide on Enspryng?
The FDA's target date (PDUFA date) for Enspryng in MOG antibody-associated disease (MOGAD) is January 10, 2027.
Who disclosed it: Genentech (Roche). The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Genentech press release
What is Enspryng being reviewed for?
Genentech (Roche) submitted a sBLA for Enspryng in MOG antibody-associated disease (MOGAD).
What to know: 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.
How it works: Humanized recycling antibody against the interleukin-6 receptor, binding both the soluble and membrane-bound forms to block IL-6 signaling.
More: the Enspryng drug page explains it in plain language.
What did the Enspryng trials show?
NMOSD approval rested on 2 Phase 3 trials, SAkuraStar (satralizumab alone) and SAkuraSky (added to existing immunosuppressants), both of which cut the risk of relapse in anti-AQP4 antibody positive patients. For thyroid eye disease, the identically designed Phase 3 trials SatraGO-1 (NCT05987423, 131 patients) and SatraGO-2 (NCT06106828, 127 patients) measured the share of active-disease patients whose eye bulging improved by at least 2 mm at week 24.
More: the Enspryng drug page has the full trial history and sources.
What are the side effects of Enspryng?
The label carries no boxed warning. Its warnings are the ones shared by IL-6 receptor blockers: an increased risk of infections including serious and potentially fatal ones, raised liver enzymes, lowered neutrophil counts and hypersensitivity reactions.
Most common: Nasopharyngitis, Headache, Upper respiratory infection, Gastritis, Rash, Joint and limb pain.
More: the Enspryng drug page lists the warnings in full.
How much will Enspryng cost?
Genentech (Roche) has not announced a price. Drugmakers usually set it around approval.
Drugmaker help: Genentech Access Solutions for Enspryng.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Enspryng decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
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.