ENSPRYNG (satralizumab)
Moderate-to-severe thyroid eye disease · Adults with moderate-to-severe active thyroid eye disease
RHHBY · Roche Holdings AG
Regulatory designations
Full timeline
3 milestonesFDA decision expected
FDA assigned an October 15, 2026 PDUFA goal date to the ENSPRYNG supplemental BLA for thyroid eye disease.
Roche — Enspryng sBLA acceptance and PDUFA date↗FDA accepted the sBLA with Priority Review
FDA accepted the ENSPRYNG supplemental BLA and granted Priority Review for the treatment of thyroid eye disease.
Roche — Enspryng sBLA acceptance and Priority Review↗SatraGO Phase 3 data were presented
Roche presented Phase 3 SatraGO-1 and SatraGO-2 results showing improvements across key thyroid eye disease endpoints, including proptosis and diplopia.
Roche — SatraGO programme data and regulatory update↗Related News
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