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FDA grants Priority Review for ocrelizumab


The U.S. Food and Drug Administration accepted for review Genentech’s Biologics License Application for Ocrevus™ (ocrelizumab) for the treatment of relapsing and primary progressive multiple sclerosis, and granted the application Priority Review designation with a Dec. 28 targeted action date. If approved, Ocrevus would be the first and only treatment indicated for both forms of MS, which affect approximately 95 percent of people at diagnosis.

Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. 

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