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WHITEHOUSE STATION, N.J. — Merck has received approval from the Food and Drug Administration for Liptruzet, a combination treatment for elevated low-density lipoprotein (LDL) cholesterol, or "bad" cholesterol.
The pharmaceutical company said Friday that Liptruzet contains ezetimibe, an efficacious LDL cholesterol-lowering therapy, and atorvastatin, one of the most widely prescribed statins.
Taken once a day, Liptruzet treats two sources of cholesterol by inhibiting the absorption of cholesterol in the digestive tract through ezetimibe and the production of cholesterol in the liver through atorvastatin.
FDA approved Liptruzet for use in patients with primary or mixed hyperlipidemia, as an adjunct to diet when diet alone isn’t enough, according to Merck.
Plans call for Liptruzet (ezetimibe and atorvastatin) to become available for wholesalers to order starting the week of May 6.
Merck said Liptruzet will be offered as once-daily tablet containing 10 mg of ezetimibe combined with 10, 20, 40 or 80 mg of atorvastatin (Liptruzet 10/10, 10/20, 10/40, 10/80 mg, respectively). The dosage range is 10/10 mg per day through 10/80 mg per day.
"A significant percentage of patients are unable to lower their LDL cholesterol to recommended levels despite treatment," stated Peter Jones, M.D., associate professor of medicine at Baylor College of Medicine. "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."
