Roche
Roche reports FDA approval of Enspryng for adults with thyroid eye disease
Roche said the U.S. FDA approved Enspryng (satralizumab) for adults with thyroid eye disease (TED). According to the company, patients or caregivers can administer the subcutaneous treatment at home after training from a healthcare provider. Roche reported that SatraGO-1 missed its primary efficacy endpoint at week 24, while SatraGO-2 improved proptosis and diplopia responses versus placebo in the active TED population. The company reported no new safety signals in the trials, with a safety profile consistent with its existing NMOSD use. For the separate MOGAD indication, Roche described priority review of an application, with an approval decision expected in January 2027.
原披露:2026/10/16 13:00 北京时间(minute 精度)
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公开收录:2026/10/16 17:01 北京时间