SOUTH SAN FRANCISCO, Calif., October 15, 2026

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng® (satralizumab-mwge) for treating adults with thyroid eye disease (TED). The approval introduces the first and only at-home subcutaneous treatment option for adults with the condition, allowing patients or trained caregivers to administer treatment. Enspryng is an interleukin-6 receptor (IL-6R) inhibitor designed to block inflammatory signaling involved in TED. The decision is supported by findings from the Phase III SatraGO-1 and SatraGO-2 clinical program, with SatraGO-2 demonstrating improvements in eye bulging and double vision. The approval expands Enspryng’s use beyond its existing indication for neuromyelitis optica spectrum disorder (NMOSD) and provides another treatment approach for people affected by this autoimmune eye disease.

Phase III Results Support FDA Approval

The FDA approval follows evaluation of Enspryng in the pivotal Phase III SatraGO program, which included two randomized, placebo-controlled studies enrolling a combined 258 patients across 19 countries. In SatraGO-2, the proptosis response rate among patients with active TED was 52.9% with Enspryng compared with 23.4% with placebo. The study also reported a reduction in diplopia, or double vision, in 60.7% of patients receiving Enspryng versus 25.8% receiving placebo. Consistent findings were reported in the overall SatraGO-2 population, which included patients with active and chronic TED. However, SatraGO-1 did not meet its prespecified primary efficacy endpoint at week 24. Genentech reported that no new safety signals were identified across the SatraGO studies, and the safety profile was consistent with Enspryng’s established profile in NMOSD. These findings contributed to the overall evidence considered in the regulatory decision.

At-Home Administration Offers Greater Treatment Flexibility

Enspryng is the first and only subcutaneous treatment option approved for TED, with at-home administration possible following training from a healthcare professional. During the maintenance phase, treatment can be administered every four weeks, offering an alternative to infusion-based treatment arrangements. The medicine is a humanized monoclonal antibody that binds to soluble and membrane-bound interleukin-6 receptors (IL-6R), inhibiting IL-6-mediated signaling associated with inflammation. It incorporates Chugai’s proprietary antibody recycling technology, designed to enable repeated target engagement and sustained inhibition of IL-6 signaling. Thyroid eye disease can cause eyelid retraction, swelling, redness, proptosis and double vision, with severe cases potentially resulting in vision-threatening complications. Genentech estimates that TED affects approximately 155 people per 100,000 in the United States. The availability of a subcutaneous option may provide additional flexibility for patients and healthcare professionals managing the condition.

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Expanding Enspryng’s Autoimmune Disease Development Program

The TED approval marks Enspryng’s second FDA-approved indication, following its 2020 approval for adults with aquaporin-4 antibody-positive NMOSD. Genentech is also pursuing development in other neurological autoimmune and inflammatory diseases that may respond to IL-6 inhibition. In September 2026, the FDA granted priority review to the company’s supplemental Biologics License Application for myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), with a regulatory decision expected in January 2027. Additional research programs include autoimmune encephalitis and other conditions involving inflammatory signaling. Genentech said it offers patient support services through Genentech Access Solutions to help eligible patients navigate access and reimbursement. The FDA approval of Enspryng for TED expands the medicine’s clinical use and introduces a new administration option for adults living with the disease. Continued development will determine its role across additional autoimmune indications and patient populations.

Source:::Genentech,press release