Roche has announced that the US Food and Drug Administration (FDA) has approved Enspryng (satralizumab) for the treatment of adults with Thyroid Eye Disease (TED), providing patients with the first and only at-home subcutaneous treatment option. Enspryng can be administered by a person living with TED or a caregiver following training from a health care provider.

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, Roche, said, “Today’s FDA approval of Enspryng provides an important new option for people with Thyroid Eye Disease, who have long faced limited treatment choices. As the first subcutaneous treatment for this condition, Enspryng offers a positive safety and efficacy profile and the potential for at-home administration.”

The totality of data from the pivotal phase 3 SatraGO program (SatraGO-1 and SatraGO-2) provided clinically meaningful improvements in patients with TED. While SatraGO-1 did not meet its pre-specified primary efficacy endpoint at week 24, SatraGO-2 achieved significant and clinically meaningful difference in proptosis response (52.9 percent in the Enspryng group compared to 23.4 percent in the placebo group) and in diplopia reduction (60.7 percent in the Enspryng group compared to 25.8 percent in the placebo group) in the active TED population.

Consistent results were achieved in the overall population (including both active and chronic patients) in SatraGO-2. No new safety signals were identified in the SatraGO trials, with Enspryng’s safety profile consistent with its known profile in neuromyelitis optica spectrum disorder (NMOSD). Full results were shared at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium in October 2025.

César A Briceño, MD, Clinical Trial Investigator and Associate Professor of Ophthalmology at the Scheie Eye Institute, University of Pennsylvania, said, "Treating Thyroid Eye Disease requires balancing efficacy, safety, and the practical realities of long-term treatment. As a clinical trial investigator, I have seen firsthand the potential of targeted therapies such as Enspryng. The availability of an effective subcutaneous treatment option could provide greater flexibility for both patients and physicians while reducing the logistical burden associated with infusion-based therapies. Enspryng has the potential to meaningfully expand our therapeutic options for patients with thyroid eye disease.

The approval in TED, following a Priority Review (PR) designation, marks the second indication for Enspryng, following an approval in neuromyelitis optica spectrum disorder (NMOSD) in 2020. This follows a recent acceptance by the FDA for PR in Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD). Enspryng is also being studied in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling.

Christine Gustafson, Chief Executive Officer, TED Community Organisation, said, “Thyroid Eye Disease not only affects a person’s eyes through bulging and vision problems, but it also takes a profound emotional toll on confidence, identity, relationships and daily life. Until now, our community has had very limited choices. The approval of Enspryng represents a critical turning point through a convenient, targeted option.”

SatraGO-1 (NCT05987423) and -2 (NCT06106828) are identically designed, phase 3, randomised, placebo-controlled, multicenter studies to determine the efficacy, durability and tolerability of Enspryng for the treatment of adults with active, moderate?to?severe TED and chronic TED. The studies enrolled a total of 258 patients from 19 countries. Participants were randomised 1:1 to receive Enspryng or placebo. The primary endpoints were the proportion of participants with active, moderate-to-severe TED who achieved an at least 2 mm reduction in proptosis in the study eye from baseline at week 24.

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 percent of whom experience at least mild TED, but it can also affect people with hypothyroidism or normal thyroid function.

Despite existing approved treatments for TED, a medical need remains for therapies that are effective, well-tolerated, and have a convenient route of administration.

Enspryng, developed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that is designed to bind to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signalling, a known key pathway involved in inflammation. It incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signaling.

Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the European Union (EU) and US, with a well established safety profile in more than 16,000 patients.

Roche is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling, including autoimmune encephalitis (AIE) and Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD). The FDA granted PR of the Enspryng supplemental Biologics License Application (sBLA) for MOGAD in September 2026 with an approval decision expected in January 2027.

Enspryng has Orphan Drug Designation (ODD) in the US and EU for NMOSD and MOGAD and in the US for anti-NMDA receptor autoimmune encephalitis (anti-NMDAR AIE) and leucine-rich glioma-inactivated 1 autoimmune encephalitis (LGI1 AIE).