ARTICLE | Regulation
LDL in context
What FDA PCSK9 panel says about LDL as a surrogate of CV benefit
June 15, 2015 7:00 AM UTC
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...