LDL in context

Discussion at last week's advisory committee meeting for the PCSK9 inhibitors Repatha evolocumab and Praluent alirocumab suggest that, for first-in-class hypercholesterolemia candidates, the agency and the committee are leaning toward narrowing the use of LDL as a surrogate endpoint to populations not well served by statins.

It appears likely that familial hypercholesterolemia (FH) is in, and - if the agency follows the panel's advice - the surrogate also may be acceptable for high-risk patients who are taking statins but continue to have heart attacks...