CETP class shelved as Merck pulls out
- In a largely expected move, Merck & Co. has decided not to file for approval of its cholesterol-lowering drug anacetrapib, despite positive, albeit underwhelming, late-stage results.
- The company attributed the decision to a review of the clinical profile of the cholesteryl ester transfer protein (CETP) inhibitor.
- In June, Merck announced its REVEAL outcomes study showed anacetrapib reduced major coronary events, but the full data presented in August showed that effect was minimal.
Merck was the final hold-out on the CETP class of drugs, continuing to pursue anacetrapib after several other big pharmas had abandoned their efforts in the space.
Investors and analysts thought there was a glimmer of hope for the class when Merck announced this summer that the drug showed some benefit in a large cardiovascular outcomes study. Yet, a rollout of the full data showed that anacetrapib only reduced the risk of major coronary adverse events by 9% compared with placebo.
At the time of the full data release in August, Merck was uncertain on whether it would choose to file for approval of the drug.
Pfizer Inc., Eli Lilly & Co. and Roche AG all have previously decided to cut their losses when it came to the CETP class, having each experienced major clinical failures with their respective drugs.
Amgen Inc still lists a mid-stage CETP inhibitor it acquired in 2015 in its pipeline, but has delayed further development pending competitor clinical trials (likely Merck), according to a recent filing with the Securities and Exchange Commission.
Cholesterol drugs are a tricky space for pharma. Statins like Lipitor (atorvastatin) and Crestor (rosuvastatin) were once the best-selling drugs in the world and went a long way to padding pharma's bottom line. As those went off patent, big pharma began testing new cholesterol treatments that could replace the statin class.
Yet those efforts have largely been for naught. Only a few new cholesterol drugs have hit the market in the last five years, and high price tags as well as administration issues have contributed to weaker-than-expected commercial performance.
While Merck might have garnered an approval based on the REVEAL data, the company would've been throwing good money after bad to successfully promote the drug and unseat still-successful statins.
- Merck & Co. Statement
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