Roche | MEDIA
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FDA grants Priority Review to Roche’s Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED)
The U.S. Food and Drug Administration has accepted and granted priority review for Enspryng (satralizumab) for the treatment of thyroid eye disease. This decision is based on positive results from the global phase III SatraGO-1 and SatraGO-2 studies. These studies demonstrated consistent, clinically meaningful improvements in key efficacy endpoints for active thyroid eye disease. Specifically, Enspryng showed significant reductions in proptosis (bulging eyes) and improvements in diplopia (double vision). The drug's safety profile was consistent with its known profile in other conditions. Enspryng targets the underlying biology of thyroid eye disease, an autoimmune condition that can cause disfigurement and vision loss. If approved, Enspryng has the potential to be the first at-home subcutaneous disease-modifying standard of care for thyroid eye disease. The FDA is expected to make a decision on its approval by October 15, 2026. This represents an important step in expanding treatment options for patients with this debilitating condition.