Roche Wins US FDA Approval for Enspryng in Thyroid Eye Disease

MT Newswires · 2d ago
01:40 AM EDT, 10/16/2026 (MT Newswires) -- Roche (RO.SW) secured the US Food and Drug Administration's approval for Enspryng as an at-home treatment for thyroid eye disease in adult patients. The Swiss-listed drugmaker said Friday the decision was backed by the results of the late-stage SatraGO-1 and SatraGO-2 trials, in which Enspryng showed clinically meaningful improvements in patients with the condition. In SatraGO-2, Enspryng showed a 52.9% proptosis response and a 60.7% reduction in diplopia, compared with 23.4% and 25.8% in placebo groups, respectively. The SatraGO-1 trial did not meet the pre-specified primary efficacy endpoint following 24 weeks of treatment. Enspryng, or satralizumab, is also authorized for neuromyelitis optica spectrum disorder. Roche is also evaluating the drug for additional neurological autoimmune and inflammatory diseases.