Merck axes cholesterol drug despite phase 3 success

Merck & Co has said it will not file its cholesterol drug anacetrapib with regulators, saying that trial results are not good enough for clinical filings.

The news came in a brief statement, which followed a surprise success for anacetrapib in the large multi-billion dollar phase 3 REVEAL trial earlier this year.

Merck & Co was the last big pharma developing a drug from the CETP class, after companies including Pfizer, Eli Lilly and Roche all scrapped development programmes following safety or efficacy issues.

The news from Merck means that industry has effectively given up on a class of drugs that a decade ago looked like being the next big thing in cardiology.

CETP (cholesterol ester transfer protein) drugs are designed to reduce levels of “bad” LDL cholesterol and boost levels of “good” HDL cholesterol, to reduce likelihood of fatty plaques in arteries that can restrict blood flow and lead to heart attacks and strokes.

Merck said it had made the decision after reviewing the clinical profile of anacetrapib, including discussions with external experts.

While Merck’s official statement suggests the drug would not get past regulators, the speculation is that anaceptrib could gain FDA approval, but would be unlikely to find a market because of the marginal efficacy gains.

The drug met a primary endpoint by reducing major coronary events (coronary death, myocardial infarction, or coronary revascularisation) by 9%.

But REVEAL missed a secondary endpoint of major atherosclerotic events (myocardial infarction, coronary death, or presumed ischaemic stroke).

It is the second drug development programme scrapped by Merck & Co in recent weeks, after the company axed development of its hepatitis C medicines after deciding their market potential was too weak amid tough competition from the likes of Gilead and a dwindling patient population.

Merck’s Roger Perlmutter

Roger Perlmutter, president of Merck Research Laboratories, said: ““We are deeply grateful to the researchers and patients who participated in the anacetrapib clinical development programme, 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.”

“During the past half-century, Merck has made numerous, important contributions to the treatment of cardiovascular disease. Our work in cardiovascular research continues.”

Merck now has one cardiovascular candidate left in phase 3: vericiguat, an oral soluble guanylate-cyclase (sGC) stimulator being studied as a new heart failure treatment.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.