- 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)