Roche announced the US Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental biologics license application for Enspryng (satralizumab) for the treatment of thyroid eye disease (TED). The filing acceptance is based on results from the 2 randomized, placebo-controlled global phase 3 SatraGO studies (SatraGO-1 and SatraGO-2) assessing the safety and efficacy of Enspryng in patients with moderate to severe TED. The FDA is expected to make a decision on approval by October 15, 2026, the company said in a press release.

According to Roche, the totality of data from the pivotal phase 3 SatraGO program demonstrated that Enspryng provided consistent, clinically meaningful improvements across key TED signs and symptoms, with a favorable and differentiated safety profile. For the primary endpoint of proptosis response at week 24, 53% of patients treated with Enspryng in SatraGO-2 achieved a proptosis reduction compared to 23% of patients treated with placebo, meeting statistical significance.

Similarly, in the SatraGO-1 trial, 49% of patients achieved a proptosis response compared to 31% in the placebo arm. While this numerical improvement did not meet statistical significance, the company said SatraGO-1 offers additional confirmatory evidence regarding the potential benefit of satralizumab in this setting. Enspryng also drove notable improvements in secondary measures across both studies, achieving reductions in clinical activity score for 78% to 90% of patients with active TED and improving double vision (diplopia) for 44% to 61% of patients with active TED in SatraGO-1 and SatraGO-2 respectively.

No new safety signals were identified in the SatraGO trials, with Enspryng’s safety profile consistent with its known profile in neuromyelitis optica spectrum disorder, the company said in the press release. OM