Merck announced that it will not submit applications for regulatory approval of anacetrapib, a novel agent being investigated for the prevention of cardiovascular disease. The decision follows a review of the clinical profile of the treatment and discussions with external experts.
“Unfortunately, after comprehensive evaluation, we have concluded that the clinical profile for anacetrapib does not support regulatory filings,” said Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories.
Results from a study (‘REVEAL’) funded by the company were presented earlier this year which found that anacetrapib was associated with a slightly lower incidence of major coronary events for patients with atherosclerotic vascular disease. The study included a total of 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy. Results found that the primary outcome, the first major coronary event, occurred in 10.8% of those in the anacetrapib group vs. 11.8% in the placebo group. The difference in the key secondary composite outcome of major atherosclerotic events (myocardial infarction, coronary death or presumed ischemic stroke) did not reach statistical significance (0.93; 95% CI, 0.86–1.00; P=0.052).
The safety of anacetrapib was generally consistent with data from earlier trials, however, a sub-study showed that anacetrapib accumulates in adipose tissue with prolonged dosing. Anacetrapib also produced small increases in systolic and diastolic blood pressures of 0.7 mmHg and 0.3 mmHg, respectively.
Anacetrapib is a selective inhibitor of cholesteryl ester transfer protein (CETP), with effects on high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and cholesterol efflux.
For more information visit Merck.com.