FDA Approves Roche’s Enspryng For Adults With Thyroid Eye Disease, First At-Home Subcutaneous Option; SatraGO-2 Proptosis Response 52.9% Vs 23.4% Placebo, SatraGO-1 Missed Primary Endpoint

The FDA has approved Roche's Enspryng (satralizumab) as the first at-home subcutaneous treatment for adults with Thyroid Eye Disease (TED). This approval is based on Phase III SatraGO-2 study results, which showed a proptosis response rate of 52.9% compared to 23.4% for the placebo, while SatraGO-1 did not meet its primary endpoint. Enspryng offers a flexible treatment option administered every four weeks during the maintenance phase, targeting a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the US.