Posted by Michael Wonder on 02 Jul 2026
FDA grants priority review to Roche’s Enspryng, the first and only at home subcutaneous treatment option for thyroid eye disease
30 June 2026 - Roche announced today that the US FDA has accepted and granted priority review to a supplemental biologics license application for Enspryng (satralizumab) for the treatment of thyroid eye disease.
The filing acceptance is based on results from the two randomised, placebo-controlled global Phase 3 SatraGO studies assessing the safety and efficacy of Enspryng in patients with moderate to severe thyroid eye disease,
The FDA is expected to make a decision on approval by 15 October 2026.
