FDA accepts Roche’s Enspryng BLA for priority review

Swiss pharma giant Roche (ROG: SIX) today announced that the US Food and Drug Administration (FDA) has 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 is based on results from the two randomised, placebo-controlled global Phase III SatraGO studies assessing the safety and efficacy of Enspryng in patients with moderate to severe TED. The data were presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) in October 2025. The FDA is expected to make a decision on approval by October 15, 2026.