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 (more than...