FDA grants Priority Review to Enspryng for MOGAD following Phase III results

The U.S. Food and Drug Administration has granted Priority Review to Roche’s supplemental Biologics License Application for Enspryng (satralizumab) as a potential treatment for myelin oligodendrocyte glycoprotein antibody associated disease, known as MOGAD.

If approved for this indication, Enspryng would become the first and only disease modifying therapy available for people with MOGAD.

The regulatory submission is supported by findings from the Phase III METEOROID study, which demonstrated clinically meaningful benefits for patients with the rare neurological condition. The FDA is expected to issue its decision on the MOGAD application by 10 January 2027.

This is the second Priority Review awarded to Enspryng by the FDA. The agency also granted Priority Review to the therapy for thyroid eye disease in June 2026.

Roche is also pursuing approval in Europe. The European Medicines Agency has validated the company’s application for Enspryng in MOGAD, with a European Commission decision anticipated during the third quarter of 2027.

Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said MOGAD can have a severe and unpredictable impact on patients because individual relapses may result in permanent neurological damage. He noted that no treatments are currently approved for the disease and said Enspryng could significantly reduce serious attacks while lowering patients’ dependence on high dose steroids and immunosuppressive medicines.

Results from METEOROID were presented at the American Academy of Neurology Annual Meeting in April 2026. The Phase III trial achieved its primary endpoint, which measured the time from randomisation to a patient’s first MOGAD relapse during the double blind treatment period.

Treatment with Enspryng reduced the risk of a new relapse by 68% compared with placebo, with a p value of 0.0025. At 48 weeks, 87% of patients receiving Enspryng remained free from relapse, compared with 67% of participants in the placebo group.

Benefits were also observed across important secondary measures. Enspryng produced significant improvements in annualised relapse rate, MRI lesion activity and the use of rescue therapy.

Safety findings from METEOROID were consistent with more than a decade of clinical trial and post approval experience with Enspryng in neuromyelitis optica spectrum disorder, or NMOSD.

MOGAD is a rare autoimmune disorder in which the immune system mistakenly attacks parts of the central nervous system. Episodes can affect the optic nerves, brain or spinal cord and may result in symptoms including vision loss, confusion, muscle weakness and disability.

Enspryng was developed by Chugai, a member of the Roche Group. The humanised monoclonal antibody targets the activity of the interleukin 6 receptor. Interleukin 6 is an important chemical messenger involved in inflammatory responses within the body.

The treatment uses recycling antibody technology that allows sustained inhibition of interleukin 6 signalling. Compared with conventional antibody technology, this approach enables Enspryng to repeatedly bind to the interleukin 6 receptor and provide rapid and sustained suppression of inflammatory pathways.

Enspryng is currently the first and only interleukin 6 inhibitor approved for NMOSD and is available for the condition in approximately 90 countries, including the U.S. and European Union. Its established safety profile includes experience in more than 10,000 patients.

Roche is also investigating Enspryng across additional neurological autoimmune and inflammatory diseases that could benefit from suppression of interleukin 6 signalling. These include autoimmune encephalitis and thyroid eye disease.

The medicine has received orphan drug designation in both the U.S. and European Union for NMOSD and MOGAD. In the U.S., it also holds orphan drug designation for anti NMDA receptor autoimmune encephalitis and leucine rich glioma inactivated 1 autoimmune encephalitis.

The FDA granted Priority Review to a separate supplemental Biologics License Application for Enspryng in thyroid eye disease in June 2026, with an approval decision expected in October 2026.

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Related Topics and Keywords

autoimmune disease, clinical trials, ENSPRYNG, mogad, neurology, neuroscience, pharma news, Roche