Roche has disclosed today that the US Food and Drug Administration (FDA) has agreed to review a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) designated for treating thyroid eye disease (TED). The submission has been granted priority review, and the decision is anticipated by 15 October 2026. This development is based on findings from two global phase III SatraGO studies that were showcased at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) in October 2025. These studies evaluated the safety and efficacy of Enspryng in patients struggling with moderate to severe TED.