US FDA approves Merck & Co's combo cholesterol drug Liptruzet

The Food and Drug Administration has approved pharma giant Merck & Co’s (NYSE: MRK) Liptruzet (ezetimibe [Merck’s Zetia] and atorvastatin [Pfizer’s Lipitor]) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. Liptruzet ezetimibe, an efficacious LDL cholesterol lowering therapy, and atorvastatin, currently one of the most widely prescribed statins in the USA, and now off patent.

Once-daily Liptruzet treats two sources of cholesterol by inhibiting both the absorption of cholesterol in the digestive tract - through ezetimibe - and the production of cholesterol in the liver - through atorvastatin. No incremental benefit of Liptruzet on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin alone has been established. This concerned some cardiologists, who questioned why the combination drug was approved.

A significant percentage of patients are unable to lower their LDL cholesterol to recommended levels despite treatment,” said Peter Jones, associate professor of medicine, Baylor College of Medicine, quoted by Merck. “Along with a healthy diet, Liptruzet is an effective new lipid-lowering treatment option that may help address this unmet need as the complementary actions of its components can provide significant additional LDL lowering beyond atorvastatin therapy alone,” he noted.