Roche’s Enspryng (satralizumab), a thyroid eye disease (TED) treatment, has been accepted by the FDA and given priority review for a supplemental Biologics License Application (sBLA).
The filing acceptance is based on results from the two randomised, placebo-controlled global phase 3 SatraGO studies assessing the safety and efficacy of Enspryng in patients with moderate to severe TED.
TED, also known as Graves’ ophthalmopathy, is a complex inflammatory autoimmune disease, affecting the area around the eyes and the eyes themselves, that can be sight-threatening, debilitating and disfiguring. The most common symptoms are redness, swelling of the eyes, eyelid retraction, appearance of a stare, bulging of one or both eyes (proptosis), double vision (diplopia) and pain.
TED is a progressive rare disease that affects approximately 155 people out of every 100,000. It most commonly occurs in people with hyperthyroidism, approximately 50% of whom experience at least mild TED, but it can also affect people with hypothyroidism or normal thyroid function.
Data from the pivotal phase 3 SatraGO programme demonstrated that Enspryng provided consistent, clinically meaningful improvements across key TED signs and symptoms, with a favourable and differentiated safety profile compared to currently available treatments.
Enspryng also drove notable improvements in secondary measures across both studies, achieving reductions in clinical activity score (CAS) for 78-90% of patients with active TED and improving double vision (diplopia) for 44-61% of patients with active TED in SatraGO-1 and SatraGO-2 respectively.
“The FDA’s decision to grant priority review to Enspryng is an important step toward expanding treatment options for people living with thyroid eye disease,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “By targeting the underlying disease biology with a novel mechanism of action, this subcutaneous therapy has the potential to introduce a new treatment approach that combines clinical efficacy and a favourable safety profile with the convenience of at-home administration.”
The data was presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) in October 2025.
The FDA is expected to make a decision on approval by 15 October 2026.