FDA approves Enspryng as first at-home subcutaneous treatment for thyroid eye disease

Roche has received U.S. Food and Drug Administration approval for Enspryng, also known as satralizumab, for adults with thyroid eye disease.

The approval makes Enspryng the first and only at-home subcutaneous treatment option for the condition.

Following appropriate training from a healthcare professional, the medicine can be administered by patients themselves or by a caregiver.

During the maintenance phase, Enspryng is given once every four weeks.

Satralizumab is an anti-IL-6 receptor monoclonal antibody designed to inhibit interleukin-6 signalling, a pathway involved in autoimmune inflammation.

The approval was supported by findings from the Phase III SatraGO-1 and SatraGO-2 studies.

Although SatraGO-1 did not meet its prespecified primary efficacy endpoint at week 24, SatraGO-2 demonstrated significant improvements in key measures of thyroid eye disease.

Among patients with active disease, 52.9% of those receiving Enspryng achieved a proptosis response compared with 23.4% of patients receiving placebo.

Proptosis refers to the abnormal forward bulging of the eye, one of the characteristic features of thyroid eye disease.

Improvement in diplopia, or double vision, was also greater with treatment.

At the assessed time point, 60.7% of patients receiving Enspryng experienced a reduction in diplopia compared with 25.8% of those receiving placebo.

Roche said consistent results were also observed across the broader SatraGO-2 population, including patients with both active and chronic disease.

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche, said the approval provides patients with an additional targeted treatment option while allowing greater flexibility through at-home administration.

César A. Briceño, MD, Associate Professor of Ophthalmology at the University of Pennsylvania and a SatraGO investigator, said thyroid eye disease treatment requires consideration of both clinical outcomes and the practical demands of longer-term therapy.

He said the availability of a subcutaneous option could reduce some of the logistical burden associated with infusion-based treatment.

No new safety signals were identified across the SatraGO programme.

The safety profile of Enspryng was consistent with its established use in neuromyelitis optica spectrum disorder.

Thyroid eye disease is a rare autoimmune condition that can cause eye bulging, double vision and other potentially serious complications.

Roche estimates that the condition affects around 155 people per 100,000 in the U.S.

In more severe cases, the disease can lead to facial changes and vision-threatening complications.

The thyroid eye disease approval is the second U.S. indication for Enspryng following its 2020 approval in neuromyelitis optica spectrum disorder.

The medicine is also under FDA Priority Review for myelin oligodendrocyte glycoprotein antibody-associated disease and is being studied in additional autoimmune and inflammatory conditions involving IL-6 signalling.

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