pharmatimesOctober 13, 2017
Tag: msd , anacetrapib
MSD has decided to pull the plug on its late-stage cholesterol drug anacetrapib after a lacklustre performance in clinical trials.
The company said it would not file for approval of the investigational cholesteryl ester transfer protein (CETP) inhibitor on the back of a review of its clinical profile that included discussions with external experts.
"Unfortunately, after comprehensive evaluation, we have concluded that the clinical profile for anacetrapib does not support regulatory filings," said Roger Perlmutter, president of Merck Research Laboratories.
Earlier this year the firm presented data from the 30,000 patient REVEAL trial showing that the drug cut the risk of major coronary events by nine percent versus placebo in patients with cardiovascular disease already taking LDL-C lowering therapy alongside atorvastatin.
Compared with placebo, the addition of anacetrapib further reduced the mean level of non-HDL cholesterol by 18 percent and increased HDL cholesterol level by 104 percent at the study midpoint.
The difference in the key secondary composite outcome of major atherosclerotic events (myocardial infarction, coronary death or presumed ischaemic stroke) did not reach statistical significance.
Anacetrapib works by inhibiting a protein called cholesterol ester transfer protein (CETP), which is designed to lift HDL - or good - cholesterol. However, the class of drugs has been hit with a series of high-profile failures because of safety issues and mediocre efficacy.
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