May 3rd, 2013
FDA Approves Combination of Ezetimibe and Atorvastatin
The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin.
Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a once-daily tablet combining 10 mg of ezetimibe with either 10, 20, 40, or 80 mg of atorvastatin. In clinical trials Liptruzet lowered LDL cholesterol by 53% to 61%, depending on dosage.
Merck said the drug had been approved for the treatment of elevated LDL cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. It is also indicated in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Prior to going off patent in 2011, atorvastatin (Lipitor, Pfizer) had been the best-selling drug in the world for many years. Ezetimibe, marketed as Zetia, and, in combination with simvastatin, as Vytorin, was also a blockbuster, though in recent years its popularity has diminished as a result of controversy over the drug’s research program and the lack of evidence demonstrating clinical benefits beyond lowering the surrogate endpoint of LDL cholesterol. The Merck press release acknowledges this:
No incremental benefit of LIPTRUZET on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established.”