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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

Benzinga·10/16/2026 05:47:40
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  • FDA approval based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement in diplopia (double vision), with a favourable safety profile, regardless of TED activity or duration
  • Enspryng (satralizumab) represents an important advance for people with TED, offering the first at-home SC treatment option every four weeks during maintenance phase, allowing for greater flexibility in how treatment is administered
  • Enspryng is an anti-IL-6R mAb using novel recycling antibody technology designed to inhibit IL-6 signalling upstream of autoantibody-driven pathology2
  • TED is a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the US that can lead to facial disfigurement and vision-threatening complications if left untreated3