The FDA granted priority review to a supplemental biologics license application for Enspryng for thyroid eye disease, according to a press release from Genentech.
Enspryng (satralizumab) is currently approved for the treatment of neuromyelitis optica spectrum disorder in patients who are aquaporin-4 antibody positive. If approved, it would become the first at-home subcutaneous treatment option for thyroid eye disease (TED).
The FDA ruling was supported by data from the phase 3 randomized, placebo-controlled global SatraGO program, which investigated Enspryng’s safety and efficacy in moderate to