Merck says cholesterol drug failed to show benefit

Drugmaker Merck & Co. said it will not seek U.S. approval for its cholesterol drug Tredaptive and is recommending doctors abroad stop prescribing it to new patients, based on failed study results.

The drug is sold in about 40 countries in Europe and elsewhere but is not a major product for Merck. In the first three quarters of 2012 the drug posted $13 million in sales.

The company said Thursday that results from a 25,700-patient study showed that adding Tredaptive to traditional statin therapy did not lower the risk of heart attack, stroke and related problems. Patients taking the cholesterol combination pill were also more likely to suffer serious, non-fatal adverse events. The study compared 4-year outcomes for patients taking Tredaptive plus statin drugs, to those taking statins alone.

Statins are a class of drugs that have long been used to lower levels of LDL, or "bad," cholesterol and slightly raise levels of HDL, or "good," cholesterol in the blood.

Tredaptive is a combination pill made up of niacin, which boosts good cholesterol, and laropiprant, which reduces the facial flushing caused by niacin.

Cowen & Co. analyst Steve Scala noted that the current statin treatment is a "high bar for a trial to overcome due to the substantial risk reduction associated with these drugs." Scala said in a research note that the uncertainty around the Tredaptive results "had been a long-standing reason to avoid Merck shares."

The Food and Drug Administration rejected Tredaptive in 2008 pending the more information about the drug's effects on the heart.

Company shares fell $1.03, or 2.4 percent, to $42.63 in morning trading.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA adds new safety information to statin drugs

Feb 28, 2012

(AP) -- Federal health officials are adding new safety warnings about risks of memory loss and elevated blood sugar to statins, a widely prescribed group of cholesterol-lowering medications.

Recommended for you

Study recalculates costs of combination vaccines

Apr 17, 2014

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

Apr 17, 2014

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

User comments