FDA extends Amgen's Repatha approval to prevent CV events

FDA approved an sBLA for Repatha evolocumab (AMG 145) from Amgen Inc. (NASDAQ:AMGN) to prevent heart attack, stroke and coronary revascularization in adults with established cardiovascular disease.

The application was based on data from the 27,564-patient FOURIER CV outcomes trial (CVOT), which showed that adding Repatha to optimized statin therapy significantly reduced the risk of major adverse CV events (MACE) vs. statin therapy alone. In June, Amgen submitted an application to EMA seeking to include the data on the drug's EU label (see BioCentury, March 24 & June 8)...