Roche announced on October 16, 2026, that the U.S. Food and Drug Administration (FDA) approved Enspryng (satralizumab) to treat adults with thyroid eye disease (TED). It is the first and only TED therapy that can be administered subcutaneously at home, offering greater convenience than existing intravenous treatments.
The approval is Enspryng’s second U.S. indication. The interleukin-6 (IL-6) receptor inhibitor is already approved to treat neuromyelitis optica spectrum disorder (NMOSD).
The FDA based its decision on data from the Phase III SatraGO clinical trial program. One of the two pivotal studies did not meet its primary endpoint, but the overall results showed clinically meaningful improvements in symptoms including eye bulging and double vision.