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Merck halts development of anacetrapib
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Merck has announced that applications will not be submitted for regulatory approval of anacetrapib, a cholesteryl ester transfer protein inhibitor for the treatment of patients with CVD.
Numerous studies have shown that anacetrapib not only raises HDL and lowers LDL, but also lowers the incidence of major coronary events when added to statin therapy.
As Cardiology Today has previously reported, results of the REVEAL trial, presented at the European Society of Cardiology Congress in August, showed anacetrapib was the first CETP inhibitor to demonstrate a reduction in CV events. Other trials of CETP inhibitors, including ILLUMINATE, dal-OUTCOMES and ACCELERATE, were stopped for futility or harm.
“We are grateful to the researchers and patients who participated in the anacetrapib clinical development program, and in particular the REVEAL outcomes study,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release. “Unfortunately, after comprehensive evaluation, we have concluded that the clinical profile for anacetrapib does not support regulatory filings.”
Disclosure: Perlmutter is an employee of Merck.
Perspective
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Steven E. Nissen, MD, MACC
It was a good decision. The clinical trial showed a small favorable effect, but it was certainly not large enough to make this a viable therapy, and the drug has a lot of baggage.
It has a very long half-life. It’s still detectable in the body 4 years after the drug is stopped, and I can think of no other drug ever developed that has that kind of persistence in tissue. If a patient were to have an allergic reaction, the drug doesn’t go away for years.
The problem with convincing regulators that it would be safe represents a huge issue.
In baseball, you get three strikes. With CETP inhibitors, we’ve had four strikes. Four therapies have failed. The mechanism is simply unlikely to produce a benefit on a background of statin treatment, and so at this point, while there is some ongoing research, I’m not terribly optimistic about the class.
I don’t think that we’re very likely to see a CETP inhibitor approved as an add-on to statins at any time in the near future.
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