FDA Grants Priority Review For Amgen's sBLA For Repatha

On July 27, Amgen announced that the U.S. Food and Drug Administration (FDA) granted priority review for the biotechnology company’s supplemental Biologics License Application (sBLA) for Repatha (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the 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 FOURIER trial results, presented at ACC.17 and simultaneously published in the New England Journal of Medicine, showed that adding Repatha to optimized statin therapy provided a 20 percent reduction in adverse cardiovascular events. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 2, 2017. Read the press release here.

Keywords: United States Food and Drug Administration, Biotechnology, Risk Reduction Behavior, Biological Products

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