Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 8 hours ago
- 1 min read
30/06/2026
FDA granted priority review to Roche’s satralizumab as a treatment option for TED (Ref)
Roche announced that the US FDA had accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of thyroid eye disease (TED).
The filing acceptance was based on results from the two randomized phase 3, SatraGO-1/ NCT05987423 and SatraG0-2/ NCT06106828 studies assessing the safety and efficacy of Enspryng in patients with moderate to severe TED.
No new safety signals were identified in the SatraGO trials, with Enspryng’s safety profile consistent with its known profile in neuromyelitis optica spectrum disorder (NMOSD).
The FDA was expected to make a decision on approval by 15 October 2026.
