Merck & Co. decides not to pursue regulatory filings for experimental cholesterol drug anacetrapib

Merck & Co. announced Wednesday that it will not seek marketing approval for its experimental CETP inhibitor anacetrapib. "After comprehensive evaluation, we have concluded that the clinical profile for anacetrapib does not support regulatory filings," stated Roger Perlmutter, president of Merck Research Laboratories. 

In August, Merck reported data from the Phase III REVEAL study, which showed that anacetrapib cut the risk of major coronary events by 9 percent versus placebo in patients with atherosclerotic vascular disease already receiving an LDL cholesterol-lowering regimen. However, the study's authors said at the time that the benefit seen in anacetrapib-treated patients was probably due to the reduction in non-HDL cholesterol, adding this "reduces the likelihood that other actions of anacetrapib played a major role in modifying the risk of coronary events," while Bernstein analyst Tim Anderson suggested Merck was unlikely to file the drug for approval.

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Merck's decision is the latest of similar moves by other drugmakers in regards to the development of CETP inhibitors. In 2015, Eli Lilly ended its programme for evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease, citing a lack of efficacy demonstrated in a late-stage study. Prior to that, Roche halted the development of dalcetrapib when it failed to show clinically meaningful benefits in a Phase III trial, while Pfizer terminated torcetrapib after a monitoring board had identified "an imbalance of mortality and cardiovascular events" in a clinical study. 

For related analysis, see ViewPoints: Merck & Co. accedes to commercial realities with anacetrapib.

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