FDA Grants Priority Review To Genentech’s Application for Enspryng, the First and Only At-Home Subcutaneous Treatment Option for Thyroid Eye Disease (TED)
The filing application is based on improvements seen across key efficacy endpoints from the global Phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED
Enspryng (satralizumab) has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED
TED is an autoimmune disease affecting approximately 155 out of every 100,000 people that can lead to facial disfigurement and vision-threatening complications if left untreated
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. 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 randomized, 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.
