SOUTH SAN FRANCISCO, Calif. — September 9, 2026

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The regulatory milestone is based on positive Phase III METEOROID results, which demonstrated a 68% reduction in the risk of MOGAD relapse compared with placebo. If approved, Enspryng could become the first and only disease-modifying therapy for MOGAD, a rare autoimmune disease affecting the central nervous system. The FDA is expected to make an approval decision by January 10, 2027, while the European Medicines Agency has also validated Genentech’s MOGAD application, with a European Commission decision expected in the third quarter of 2027.

METEOROID Data Support Significant Relapse Reduction

The Phase III METEOROID study met its primary endpoint by significantly extending the time to first MOGAD relapse during the double-blind treatment period. Enspryng reduced the risk of a new relapse by 68% versus placebo (p=0.0025), while 87% of patients receiving Enspryng remained relapse-free at 48 weeks, compared with 67% in the placebo group. The treatment also demonstrated significant improvements across key secondary measures, including annualized relapse rates, MRI lesion activity and the use of rescue therapies. METEOROID enrolled adults and adolescents aged 12 years and older and used a randomized, double-blind, placebo-controlled design. Participants received weight-based Enspryng or placebo by subcutaneous administration, initially at weeks 0, 2 and 4 and subsequently every four weeks. The findings provide the principal clinical evidence supporting Genentech’s regulatory submission and strengthen the company’s effort to establish satralizumab as a disease-modifying option in MOGAD.

Enspryng Targets IL-6 Signaling in Autoimmune Disease

Enspryng is a humanized monoclonal antibody designed to inhibit interleukin-6 (IL-6) receptor signaling, an inflammatory pathway implicated in autoimmune disease. Developed by Chugai, a Roche Group company, the therapy uses proprietary recycling antibody technology intended to provide sustained IL-6 inhibition through repeated binding to the IL-6 receptor. Its established clinical and regulatory experience provides an important foundation for expansion into MOGAD, with Enspryng already approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD). More than 10,000 patients have received the therapy through clinical trials and post-approval use, according to Genentech. The company reported that the safety profile observed in METEOROID was consistent with the established Enspryng safety experience. Genentech is also evaluating IL-6 pathway inhibition in other neurological autoimmune and inflammatory conditions, including autoimmune encephalitis and thyroid eye disease, supporting a broader strategy around the therapy’s mechanism.

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Genentech Expands Enspryng Neurology Franchise

The MOGAD Priority Review represents another major regulatory milestone in Genentech’s strategy to expand Enspryng across neurological autoimmune diseases. MOGAD can cause unpredictable attacks involving the optic nerves, brain and spinal cord, potentially resulting in vision loss, weakness, impaired mobility and other lasting neurological disability. Relapsing disease can lead to accumulating neurological damage, while no approved treatment options currently exist specifically for MOGAD. Genentech’s regulatory progress in the United States and Europe therefore creates an opportunity to address a significant unmet need while expanding the commercial and clinical reach of an established IL-6 inhibitor. The company is simultaneously pursuing an FDA decision for Enspryng in thyroid eye disease, expected in October 2026. With Priority Review in MOGAD, positive Phase III evidence and an established global safety and commercial foundation in NMOSD, Genentech is positioning Enspryng for a broader role across neurological autoimmune disorders..

Source: Genentech, press release