FDA Grants Priority Review to Genentech’s Enspryng for MOGAD

Rare Daily Staff

The U.S. Food and Drug Administration has granted Priority Review to Genentech’s application to expand the use of Enspryng for the are autoimmune condition myelin oligodendrocyte glycoprotein antibody-associated disease, or MOGAD.

The agency is expected to make an approval decision by January 10, 2027. If approved, Enspryng would become the first disease-modifying treatment authorized for MOGAD.

MOGAD is a disease in which the immune system mistakenly attacks parts of the central nervous system, including the optic nerves, spinal cord, and brain. It can cause sudden, unpredictable episodes of inflammation that may lead to vision loss, eye pain, weakness, numbness, walking difficulties, fatigue, bladder or bowel problems, and cognitive symptoms. Although people of any age can develop MOGAD, repeated attacks can leave lasting neurological damage and disability. There are currently no treatments approved specifically for the condition.

Enspryng is an antibody designed to block the activity of interleukin-6, an immune-system signaling protein involved in inflammation. The medicine is already approved in the United States and many other countries for a related rare neurological condition, neuromyelitis optica spectrum disorder. In the MOGAD study, it was administered by injection under the skin, with dosing based on body weight.

The FDA’s acceptance of the application for Priority Review was based on results from the Phase 3 METEOROID trial, which enrolled adults and adolescents ages 12 and older with MOGAD. In the double-blind portion of the study, Enspryng reduced the risk of a new relapse by 68 percent compared with placebo. At 48 weeks, 87 percent of participants receiving Enspryng had remained relapse-free, compared with 67 percent of those receiving placebo.

The study also assessed relapse rates, MRI activity, and the need for rescue treatments, such as steroids, plasma exchange, or intravenous immunoglobulin. Genentech said Enspryng’s safety profile in the trial was consistent with previous experience using the drug in neuromyelitis optica spectrum disorder. Its prescribing information warns that the medicine can increase the risk of serious infections and may affect liver enzymes and certain white blood cell counts.

Genentech also said that the European Medicines Agency has validated its application for Enspryng in MOGAD. A decision by the European Commission is anticipated in the third quarter of 2027.