Enspryng MOGAD Results
- Genentech's Enspryng (satralizumab) reduced relapse risk in MOGAD by 68% in the Phase III METEOROID trial. (x.com) - The study reported 87% of treated patients were relapse-free at 48 weeks versus 67% for placebo. (x.com) - The data support a potential first approved treatment for this rare CNS autoimmune disorder, prompting likely regulatory follow-up and safety surveillance. (x.com)
Myelin oligodendrocyte glycoprotein antibody-associated disease, or MOGAD, is a rare immune disorder in which the body attacks myelin, the insulation around nerves in the brain, spinal cord, and optic nerves. Genentech said April 21 that its drug Enspryng cut the risk of a new relapse by 68% in a Phase III trial. (gene.com) In the METEOROID study, 87% of patients on Enspryng were relapse-free at 48 weeks, compared with 67% on placebo. The primary endpoint was time to first relapse during the double-blind part of the trial, and the result reached statistical significance with p=0.0025. (gene.com) The study enrolled adults and adolescents ages 12 and older and used weight-based subcutaneous dosing every four weeks after loading doses. The data were presented in a late-breaking session at the American Academy of Neurology annual meeting in Chicago, held April 18-22, 2026. (neurologylive.com) MOGAD can cause attacks of optic neuritis, myelitis, or brain inflammation, and those attacks can leave lasting vision loss or neurological disability. Reviews of the disease describe it as a distinct inflammatory disorder of the central nervous system that can affect both children and adults. (pmc.ncbi.nlm.nih.gov) There are no approved treatments for MOGAD today, and care often relies on off-label immune therapies that vary by country, cost, and insurance coverage. Michael Levy of Massachusetts General Hospital told NeurologyLive that getting coverage for those off-label options has been a “true struggle.” (gene.com) (neurologylive.com) Enspryng is an antibody drug that blocks the interleukin-6 receptor, a signaling pathway involved in inflammation. The medicine is already approved in the United States for aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder, another rare autoimmune disease of the central nervous system. (accessdata.fda.gov) Secondary results in METEOROID also favored Enspryng: annualized relapse rate fell 66%, active magnetic resonance imaging lesions fell 79%, and 73% fewer patients needed rescue therapy. NeurologyLive reported no new safety signals, with injection reactions, influenza, joint pain, back pain, sinusitis, and diarrhea among the more common adverse events. (neurologylive.com) Genentech said the treatment effect appeared across subgroups including age, sex, race, and background therapy use, and onset was seen as early as week 8. The company said it plans to submit the METEOROID data to regulators worldwide. (gene.com) If regulators clear the new use, Enspryng would move from an approved drug in a neighboring disease to the first labeled therapy for MOGAD. For patients who now cycle through unapproved relapse-prevention regimens, the next step is no longer another case report or clinic habit, but a filing. (gene.com) (fiercepharma.com)
