Viela Bio announced the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for inebilizumab, an investigational anti-CD19 monoclonal antibody, for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis.
“The acceptance of our first BLA filing for review represents a huge milestone for inebilizumab and another important step in delivering this novel therapy to patients in need,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “We believe that inebilizumab can play a critical role in reducing the risk of developing an NMOSD attack, thereby contributing to the health of patients with this devastating and debilitating disease. We look forward to working closely with the FDA to move this therapy toward approval.”
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The safety and efficacy results provided in the application are from the pivotal N-MOmentum trial, the largest global, placebo-controlled study in NMOSD. The study, which enrolled 231 patients with and without the AQP4-IgG antibody—a key biomarker for the disease—met its primary and a majority of the secondary endpoints. Results demonstrated that inebilizumab reduced the risk of developing an NMOSD attack by 77% when compared to placebo in AQP4-IgG seropositive patients after 28 weeks of treatment. In addition, inebilizumab impacted measurements of worsening disability, hospitalizations and new central nervous system MRI lesions.