FDA approves Roche’s Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease (TED)

The FDA has approved Roche's Enspryng (satralizumab) as the first at-home subcutaneous treatment for thyroid eye disease (TED). The approval was based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating significant reductions in eye bulging (proptosis) and improvements in double vision (diplopia). Enspryng is an IL-6R inhibitor using novel recycling antibody technology and represents the second indication for the drug, following its 2020 approval for neuromyelitis optica spectrum disorder (NMOSD).