Enspryng (satralizumab)
FDA PDUFA Target Action Date · Genentech (Roche)
Note: Genentech press release dated June 29, 2026: FDA granted Priority Review to the sBLA for Enspryng (satralizumab) in thyroid eye disease, with an FDA decision expected by October 15, 2026. Based on the Phase III SatraGO-1 and SatraGO-2 studies showing improvements in proptosis and diplopia in active TED. Enspryng is an IL-6 receptor-directed antibody already approved for AQP4-IgG seropositive NMOSD; if approved in TED it would be the first and only at-home subcutaneous treatment option for the indication. (The orphan drug designations Genentech cites are for NMOSD/MOGAD/AIE, not TED, so only Priority Review is recorded here.) [UPDATE 2026-10-06: Roche release of 2026-09-10 restates the TED decision as expected in October 2026 (the exact 15 October date is from the 2026-06-30 release). Source: https://www.roche.com/media/releases/med-cor-2026-09-10]
Drug Information
- Drug Name
- Enspryng (satralizumab) (CT.gov)
- Application Type
- sBLA
- FDA Designations
- Priority Review
- Indication
- Thyroid eye disease (TED)
Filing Details
- Company
- Genentech (Roche)
- Stock Ticker
- RHHBY
- Source
- Company PR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-08-02. Report an issue