KENILWORTH, NJ — In the wake of disappointing trial results, Merck announced it will not seek regulatory approval for its investigational cholesterol drug anacetrapib[1].
In June, Merck announced top-line results from the phase 3 REVEAL study, the first major trial to show the cholesteryl ester transfer protein (CETP) inhibitor not only reduced cholesterol but also cut major coronary events.
Speculation arose about the future of the drug in August, however, when full results presented at the European Society of Cardiology (ESC) 2017 Congress showed only a modest 9% relative risk reduction in major coronary events when anacetrapib was added to intensive statin therapy.
“Unfortunately, after comprehensive evaluation, we have concluded that the clinical profile for anacetrapib does not support regulatory filings,” Merck Research Laboratories president Dr Roger Perlmutter said in a statement released Oct. 11, 2017.
This once-promising class of cholesterol-lowering drugs was already on life support before Merck’s announcement, with anacetrapib the fourth CETP inhibitor to be scrapped following Hoffman-La Roche’s dalcetrapib, Pfizer’s torcetrapib, and Eli Lilly’s evacetrapib.
Some lipid researchers at ESC 2017, however, suggested that statins may blunt the beneficial effect of CETP inhibitors on cardiovascular risk, and thus the drugs may have a role as monotherapy in patients who can’t or won’t take statins. The question now is whether any drug maker is still listening.
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