Genentech announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for Ocrevus (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
The BLA submission is supported by positive data from three randomized, double-blind, global multicenter, Phase 3 studies evaluating Ocrevus in patients with RMS (OPERA I and OPERA II) and in patients with PPMS (ORATORIO). All three studies met their primary and key secondary endpoints, demonstrating the superior efficacy of Ocrevus in reducing annualized relapse rates and disability progression sustained for at least three and for at least six months vs. Rebif (interferon beta-1a) or placebo.
The FDA has set a target action date of December 28, 2016 to complete the BLA review. If approved, Ocrevus will become the first and only treatment indicated for both forms of MS.
Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal damage.
For more information call (800) 821–8590 or visit Gene.com.