FDA approves Roche’s Enspryng (satralizumab) as an at-home injection for thyroid eye disease

Roche announced on 16 October 2026 that the US Food and Drug Administration (FDA) has approved Enspryng (satralizumab) for adults with thyroid eye disease (TED). According to the company, it is the first subcutaneous TED treatment, which can be injected at home by the patient or a carer after training, given every four weeks in the maintenance phase.

The disease and the drug

TED (Graves’ ophthalmopathy) is an autoimmune inflammatory disease that can cause eye bulging (proptosis), double vision (diplopia), swelling and pain; Roche cites a US prevalence of about 155 per 100,000 people. Satralizumab, developed by Roche group company Chugai, is a monoclonal antibody that blocks the interleukin-6 receptor. It was first approved in 2020 for neuromyelitis optica spectrum disorder; TED is its second US indication, approved after priority review.

Trial evidence — mixed

The approval rests on two identically designed, randomised, placebo-controlled Phase III trials, SatraGO-1 and SatraGO-2, with 258 patients from 19 countries in total.

• SatraGO-1 did not meet its pre-specified primary endpoint at week 24.
• In SatraGO-2, among patients with active TED, 52.9% on Enspryng achieved a proptosis response versus 23.4% on placebo, and diplopia improved in 60.7% versus 25.8%.
• Roche reports no new safety signals.

Caveats

These figures come from a company press release; full peer-reviewed results were not cited in it (data were presented at a 2025 ophthalmic surgery meeting). One of the two pivotal trials failed, and long-term durability and head-to-head comparisons with existing TED treatments are not described. Treatment decisions belong with an ophthalmologist or endocrinologist.