The days of off-label speculation may soon be over for patients with the rare autoimmune disease MOGAD, as Roche’s Phase 3 win for Enspring 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 the field, showed that Enspryn (satralizumab) reduced the risk of MOGAD recurrence by 68% compared to placebo, according to results presented at the 2026 American Academy of Neurology Annual Meeting.
MOGAD (Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease) is a rare disease in which the immune system attacks the myelin sheath that protects nerve fibers, causing symptoms similar to multiple sclerosis, including vision loss, muscle dysfunction, seizures, and headaches.
Unlike MS and another neuroinflammatory disease, neuromyelitis optica spectrum disorder (NMOSD), MOGAD is characterized by the presence of MoG-IgG autoantibodies.
Because MOGAD is a relatively newly defined disease, there are no FDA-approved treatments. Patients are currently being treated with immunosuppressive drugs such as corticosteroids, azathioprine, and mycophenolate mofetil, but these are supported only by empirical evidence, Friedemann Pohl, MD, a neuroimmunology expert at the Charity University of Berlin, explained at a press conference after sharing the Meteoroid results.
He called Enspring’s results “very impressive” and could lead to the first approved treatment to prevent seizures in MOGAD. IL-6 receptor antagonists are already approved for the treatment of 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.
Paul said the 68% reduction in new recurrences was “very statistically significant.” He added that Enspring’s treatment effects began to appear “pretty early” at about eight to 10 weeks, but the results seen between the study groups continued to diverge throughout the study period.
At 48 weeks, 87% of patients in the Enspring treatment group had no recurrence, compared with 67% in the placebo group.
The results of the secondary endpoint were “very consistent” with the primary endpoint, Paul said. These measurements include annualized rates of MOGAD recurrence, annualized rates of severe attacks, active MRI lesions, and proportion of patients receiving rescue therapy.
On the safety front, the study recorded one patient death from malignant melanoma. However, neither that nor any other serious adverse events were attributable to the treatment.
“The safety profile was almost exactly what we saw in the NMOSD trial in terms of type and frequency of adverse events,” Paul said of Enspring.
Roche telegraphed Meteoroid’s positive announcement during its fourth-quarter earnings call in January. At the time, Roche Pharmaceuticals Chief Executive Teresa Graham said the Swiss drugmaker planned to apply for approval from the US Food and Drug Administration and the European Medicines Agency in 2026, adding that the indication could net Enspring around CHF 500 million in peak sales.
Last year, sales of the antibody medicine increased by 23% in constant currencies to CHF 364.
In addition to MOGAD, Roche is also pursuing FDA approval of Enspring for the treatment of thyroid eye disease and is testing the drug in a pivotal study for autoimmune encephalitis.
Meanwhile, the company recently announced that it was withdrawing from a development program for Duchenne muscular dystrophy after struggling to recruit patients for its Phase 2 trial.
