The era of off-label guesswork for patients living with the rare autoimmune disorder MOGAD may soon be over, as a phase 3 victory for Roche’s Enspryng suggests a first-of-its-kind FDA approval may not be far away.
Data from the phase 3 Meteoroid trial—the first randomized-controlled trial in this space—showed that Enspryng (satralizumab) reduced the risk of a MOGAD relapse by 68% versus placebo, according to results presented at the American Academy of Neurology 2026 annual meeting.
MOGAD, or myelin oligodendrocyte glycoprotein antibody-associated disease, is a rare disease in which the immune system attacks the myelin sheath that protects nerve fibers, causing some of the same symptoms as multiple sclerosis, including vision loss, muscle dysfunction, seizures and headaches.
Unlike from MS and another neuroinflammatory disease neuromyelitis optica spectrum disorder (NMOSD), MOGAD is characterized by the presence of MoG-IgG autoantibodies.
As MOGAD is a relatively newly defined disease, no FDA-approved therapies exist. Patients are currently treated with immunosuppressants such as corticosteroids, azathioprine and mycophenolate mofetil, which are supported by empirical evidence only, Friedemann Paul, M.D., a neuroimmunology expert at Charité Universitätsmedizin Berlin, explained after sharing the Meteoroid results during a press conference.
He described Enspryng’s results as “very impressive,” potentially leading to the first approved therapy to prevent attacks in MOGAD. The IL-6 receptor antagonist is already approved to treat NMOSD with AQP4 antibodies.
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The Meteoroid trial enrolled 132 patients aged 12 years and older who had experienced at least two MOGAD attacks in the past two years; they were allowed to receive background therapy of immunosuppressants during the study.
The 68% reduction in new relapses was “highly statistically significant,” Paul said. Enspryng’s treatment effect started to show “fairly early on,” from about eight to 10 weeks, and the results seen between the trial arms continued to diverge over the course of the study, he added.
At 48 weeks, 87% of patients in the Enspryng arm were relapse-free, compared with 67% on placebo.
Outcomes from the secondary endpoints were “very consistent” with the primary endpoint, according to Paul. These measures included the annualized rate of MOGAD relapses, the annualized rate of serious attacks, active MRI lesions and the proportion of patients who received rescue therapy.
On the safety side, the study recorded one patient death from malignant melanoma. But neither that nor any other serious adverse events were attributed to treatment.
“The safety profile was almost exactly what we have seen in the NMOSD trials regarding the type and frequency of adverse events,” Paul said of Enspryng.
Roche telegraphed the positive Meteoroid readout during its fourth-quarter earnings report in January. At that time, Roche Pharmaceuticals chief Teresa Graham said the Swiss pharma planned to file for approvals with the U.S. FDA and the European Medicines Agency in 2026, adding that the indication could unlock about 500 million Swiss francs in peak sales for Enspryng.
Last year, the antibody drug grew sales by 23% at constant currencies to 364 Swiss francs.
In addition to MOGAD, Roche is also eying an FDA approval for Enspryng as a treatment for thyroid eye disease and is testing the drug in a pivotal study for autoimmune encephalitis.
Meanwhile, the company recently called it quits on a development program in Duchenne muscular dystrophy after struggling to recruit patients for a phase 2 trial.