Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug ocrelizumab (Ocrevus) for the treatment of primary progressive multiple sclerosis (PPMS).
PPMS is a debilitating form of MS characterized by steadily worsening symptoms with typically no distinct relapses or periods of remission. There are currently no FDA-approved treatments for PPMS. Ocrelizumab is the first investigational drug for MS to be granted Breakthrough Therapy designation.
The designation is supported by positive data from the pivotal Phase 3 study ORATORIO, a randomized, double-blind, global, multicenter trial evaluating the efficacy and safety of ocrelizumab vs. placebo in 732 PPMS patients. The primary endpoint was time to onset of confirmed disability progression (CDP) sustained for ≥12 weeks.
Results showed that patients treated with ocrelizumab had significantly reduced disability progression and other markers of disease activity compared with placebo. Detailed findings were presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2015.
Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells. Ocrevus is the proprietary name submitted to the FDA for ocrelizumab.
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