Merck requests FDA approve statin for OTC use, releases drug pipeline

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Merck appeals to FDA for its
drug pipeline. Source: Unicity

Merck today is appearing before the FDA’s Nonprescription Drugs Advisory Committee and its Endocrinologic and Metabolic Drugs Advisory Committee for the third time to request to sell its statin, Mevacor, as an over-the-counter (OTC) medicine. Simultaneously, Merck released its drug pipeline, including several cardiac-related pharmaceuticals.

After the meetings in 2000 and 2005, the FDA committees did not approve Merck’s request, concerned that patients would not be equipped to decide whether they need to take statins, and that young people for whom the drug is not indicated would be influenced by advertising.

The FDA said the committees will evaluate data submitted by Merck to support the over-the-counter use of Mevacor (lovastatin) 20 mg a day to help lower cholesterol which may prevent a first heart attack. Merck said it would be hoping to target men and women with moderate risk of heart attacks or strokes.

Statins are the most frequently prescribed medicines in the United States, and Mevacor was prescribed more than 15 million times last year, according to Bloomberg News. However, Merck believes only 6 million of the 20 million at-risk Americans are currently being treated.

According to Merck, in a study to see if participants could discern whether they should take Mevacor, 72 percent had the ability to determine whether they should take the statin. Merck said, "We are confident that the data we will present on Thursday will demonstrate that consumers can safely and effectively use" the Mevacor sold OTC, The Wall Street Journal reported.

Also this week, Peter S. Kim, MD, president of Merck Research Laboratories, said the company plans to seek marketing clearance for a new cholesterol-lowering drug and an obesity therapy in 2008, highlighting Cordaptive, the proposed brand name for MK-0524A. Also in 2008, Merck anticipates filing a new drug application (NDA) with the FDA for MK-0364, taranabant, an investigational medication for the treatment of obesity.

During his presentation, Kim also detailed seven drug candidates currently in Phase III development, including:

  •   MK-0524B is a drug candidate that combines the novel approach to raising HDL-cholesterol (HDL-C) and lowering triglycerides from extended-release niacin combined with laropiprant with the proven benefits of simvastatin in one combination product. The candidate already is in Phase III development, and Merck continues to anticipate filing an NDA for MK-0524B in 2008.
  •   MK-7418, rolofylline, is a Phase III investigational drug being evaluated for the treatment of acute heart failure. Merck acquired the drug candidate as part of the acquisition of NovaCardia and anticipates filing an NDA with the FDA in 2009.
  •   The development of MK-0859, anacetrapib, an inhibitor of the cholesterol ester transfer protein that in early clinical trials has shown promise in lipid management by raising HDL-C and reducing LDL-cholesterol without raising blood pressure.

About the final drug, MK-0859, Kim said in “clinical studies, inhibition of cholesteryl ester transfer protein raises plasma HDL-C levels and decreases LDL-C levels, which represents a potential therapeutic intervention to reduce the risk of coronary artery disease.” He added in 2008, the company plans “to initiate a sequenced Phase III program to obtain additional clinical experience in patients before initiating an outcomes study."

Peter N. Kellogg, Merck's executive vice president and CFO, said its “new and in-line pharmaceutical products and vaccines are expected to drive revenue at a compound annual growth rate of 4 percent to 6 percent from 2005 through 2010, including 50 percent of the revenues from the joint ventures from which Merck derives equity income.”