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European advisory group backs CV benefit labeling for Amgen's Repatha

Mar. 23, 2018 9:17 AM ETAmgen Inc. (AMGN) StockBy: Douglas W. House, SA News Editor
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending a cardiovascular risk reduction claim for Amgen's (NASDAQ:AMGN) Repatha (evolocumab) in adults with established atherosclerotic cardiovascular disease (heart attack, stroke or peripheral artery disease).
  • A final decision from the European Commission usually takes ~60 days.
  • The FDA approved the labeling in December 2017.
  • Shares are up 1% premarket.
  • Previously: FDA OKs inclusion of cardiovascular outcomes data in Repatha label (Dec. 1, 2017)

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