Amgen submits US/EU regulatory applications for Repatha CVOT data

Amgen Inc. (NASDAQ:AMGN) submitted an sBLA to FDA for cholesterol-lowering drug Repatha evolocumab (AMG 145) to include data from the FOURIER cardiovascular outcomes trial (CVOT). The company also submitted a variation to EMA to update Repatha's authorization with the data.

The 27,564-patient study showed that adding Repatha to optimized statin therapy significantly reduced the risk of major adverse cardiovascular events (MACE) vs. statin therapy alone (p<0.001 for both) (see BioCentury, March 27)...