Posted by Michael Wonder on 27 Aug 2019
Viela Bio announces U.S. FDA accepts for review inebilizumab biologics license application for neuromyelitis optica spectrum disorder
27 August 2019 - U.S. FDA accepts for review Viela Bio's first BLA filing.
Viela Bio today announced that the U.S. FDA has accepted for review its biologics license application for inebilizumab, an investigational anti-CD19 monoclonal antibody, for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterised by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis.
The safety and efficacy results provided in the application are from the pivotal N-MOmentum trial, the largest global, placebo-controlled study in NMOSD.
