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...