FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For Repatha ® (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events

FDA Priority Review Status Underscores Need to Reduce Heart Attacks and Strokes THOUSAND OAKS, Calif., July 27, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S. Prescribing Information for Repatha will be updated to include risk reduction of major cardiovascular events based on data from the large cardiovascular outcomes study (FOURIER). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 2, 2017. "The FDA's decision to grant priority re...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news