CETP inhibitor anacetrapib not submitted for approval
Merck (MSD outside US/Canada) announced that the company will not submit applications for regulatory approval for its investigational cholesteryl ester transfer protein (CETP) inhibitor anacetrapib. The decision follows a thorough review of the clinical profile of anacetrapib, including discussions with external experts.
“We are deeply grateful to the researchers and patients who participated in the anacetrapib clinical development program, and in particular the REVEAL outcomes study. Unfortunately, after comprehensive evaluation, we have concluded that the clinical profile for anacetrapib does not support regulatory filings,” said Roger M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories.
In August, results of the REVEAL study were presented. This study showed that four years after treatment with anacetrapib in addition to high-dose statin, a 9% reduction of the risk of a major coronary event was seen in CVD patients.
However, it appeared as though non-HDL is the main cause of the observed effect of anacetrapib, which reduces the likelihood that other actions of anacetrapib played a major role in modifying the risk of coronary events