FDA Approves Atorvastatin/Ezetimibe Combo Tablet

May 03, 2013

Dallas, Texas— The US Food and Drug Administration (FDA) has approved a new lipid-lowering combination tablet that includes atorvastatin, which went off patent in 2011, and ezetimibe (Zetia, Merck/Schering-Plough[1]. The combination, known as Liptruzet, is approved for the treatment of elevated LDL-cholesterol levels in patients with primary or mixed hyperlipidemia as an adjunct to dietary changes, as well as for reducing cholesterol levels in patients with homozygous familial hypercholesterolemia (FH).

Liptruzet is available as a once-daily tablet containing 10 mg of ezetimibe combined with 10, 20, 40, or 80 mg of atorvastatin.

The FDA approval is a third-time charm for Merck, the makers of Liptruzet. In 2012, the FDA issued a complete-response letter to the company, stating the agency would not approve the combination tablet and that more data were needed. It also rejected Merck's application for Liptruzet in 2009.

A combination tablet that includes simvastatin and ezetimibe, known as Vytorin, is already available in the US and has been since 2002.

As reported previously by heartwire, both atorvastatin and ezetimibe are very effective lowering LDL-cholesterol levels, but Vytorin and ezetimibe have been dogged by a lack of hard clinical end-point data. Most notably, the company was criticized for long delays in publishing the ENHANCE study, even attracting the watchful eye of congressional committees in the US. In ENHANCE, a population of patients with familial hypercholesterolemia, the combination of simvastatin and ezetimibe did no better than simvastatin monotherapy on several surrogate imaging end points.

The clinical-outcomes study IMPROVE-IT, which is comparing simvastatin 40 mg plus ezetimibe 10 mg with simvastatin 40 mg alone in 18 000 patients with a recent acute coronary syndrome, is expected to be completed in 2014. Although the study will help clarify the clinical benefit of adding ezetimibe, the trial results will arrive more than a decade after the FDA approved ezetimibe as an adjunct to statins for cholesterol lowering.

In January 2012, the FDA updated the prescribing information for the ezetimibe/simvastatin combination to include data from the SHARP study. In that trial, the combination was shown to more effectively lower LDL-cholesterol levels in chronic kidney disease (CKD) patients, with fewer major vascular events, when compared with placebo. However, a CKD indication for Vytorin was not approved, "because independent contributions of ezetimibe and simvastatin were not assessed."

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