Amgen’s Evolocumab At FDA: Dawn Of PCSK9 Era Still Cloudy
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Firm files BLA for eagerly-awaited PCSK9 inhibitor for high cholesterol, amid continued uncertainty on surrogate markers in cardiovascular trials; Amgen’s heart failure drug ivabradine now has priority review status from FDA and could help pave the way for evolocumab.