ARTICLE | Clinical News
Amgen sBLA gets Priority Review for Repatha CVOT data
August 16, 2017 8:07 PM UTC
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). ...
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