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Roche earns FDA approval for Enspryng in thyroid eye disease, offering the only at-home subcutaneous treatment for TED.
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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).
FDA approval based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement in diplopia (double vision), with a favourable safety profile,
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