FDA OKs Liptruzet for High LDL

The FDA approved Liptruzet, a combination of ezetimibe and atorvastatin, for the treatment of hyperlipidemia, drug maker Merck announced today.

Liptruzet is approved to treat elevated low-density lipoprotein (LDL) cholesterol in those with either primary or mixed hyperlipidemia and whose diet and lifestyle changes have not lowered their cholesterol to recommended levels.

In March 2012, the FDA sent Merck a complete response letter that requested more information on the then investigational drug.

Ezetimibe (Zetia) is a drug that lowers LDL cholesterol by decreasing its absorption in the intestine.

Atorvastatin (Lipitor) is one of the world’s best selling Statins. The generic version, which is used in Liptruzet, has been available since November 2011. It absorbs cholesterol in the liver.

Taken once daily, the drug’s dosage range is 10/10 mg/day through 10/80 mg/day.

Vytorin, a combination of ezetimibe and simvastatin (Zocor), is another Merck product for High cholesterol.

Vytorin has had its share of controversy over the years, in particular, a poor showing in the ENHANCE Trial, where it did not slow down the progression of Atherosclerosis.

Liptruzet has not shown an incremental benefit on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin, according to Merck.

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Chris Kaiser
Cardiology Editor
Chris has written and edited for medical publications for more than 15 years. As the news editor for a United Business Media journal, he was awarded Best News Section. He has a B.A. from La Salle University and an M.A. from Villanova University. Chris is based outside of Philadelphia and is also involved with the theater as a writer, director, and occasional actor.