A new drug for a rare nerve disease is showing real promise. One-year data from the phase 3 AQUARELLE trial show that divozilimab, an anti-CD20 monoclonal antibody, kept 90.5% of neuromyelitis optica spectrum disorder (NMOSD) patients relapse-free. Compared to a historical placebo arm, divozilimab cut relapse risk by nearly 90%, with mostly mild side effects reported.
A new treatment option for neuromyelitis optica spectrum disorder (NMOSD) — a rare, often debilitating autoimmune disease that attacks the optic nerves and spinal cord — is looking increasingly promising. One-year data from the phase 3 AQUARELLE trial, presented at MSToronto2026, show that divozilimab, a humanized anti-CD20 monoclonal antibody developed by Biocad, significantly reduced relapse activity in 105 enrolled patients.
Since the trial has no internal placebo arm, investigators used a matching-adjusted indirect comparison against the SAkuraStar historical placebo arm. The results were striking: divozilimab was associated with a nearly 90% lower risk of relapse versus placebo, and no patients experienced disability progression over the follow-up period. Adverse events were mostly mild to moderate, with lymphopenia and neutropenia being the most common.
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Why it matters: NMOSD is a rare but severe condition with limited treatment options. Divozilimab — already approved in Russia for relapsing MS — could expand the therapeutic toolkit for this underserved patient population, with phase 3 data now supporting its efficacy and a manageable safety profile.
