Amgen sBLA gets Priority Review for Repatha CVOT data

FDA accepted and granted Priority Review to an sBLA from Amgen Inc. (NASDAQ:AMGN) for Repatha evolocumab (AMG 145) to include data from the FOURIER cardiovascular outcomes trial (CVOT). Its PDUFA date is Dec. 2.

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 (see BioCentury, March 27). ...