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Amgen’s Evolocumab At FDA: Dawn Of PCSK9 Era Still Cloudy

 
• By Emily Hayes

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.

Amgen Inc.’s filing of a BLA for evolocumab marks a major milestone for the eagerly-awaited class of PCSK9 inhibitors seen as potential heirs to the statins’ blockbuster crowns. But for now the sword remains in the stone, and the review will be a test of whether LDL reduction still suffices as a surrogate marker in cholesterol trials.

Amgen announced on Aug. 28 that it had submitted the BLA, which includes studies of more than 6,800 patients, to FDA. The filing includes ten Phase III studies (enrolling more...

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