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Merck pushes for over-the-counter statin in US
Dec 14, 07 Patent Expiration Medical Product Safety AlertsMaking a cholesterol drug available over the counter could give millions of Americans a new option to reduce the risk of heart disease and provide a major public health benefit, drugmaker Merck & Co Inc argued to a U.S. advisory panel on Thursday.
The company is making its third bid for U.S. approval to sell a low-dose, nonprescription version of its Mevacor cholesterol-lowering pill. Mevacor is one of the statin drugs taken by millions to cut cholesterol and the risk of heart disease, the leading killer of Americans.
Moving a statin over the counter would be a major shift. Nonprescription drugs generally treat short-term conditions with easy-to-recognize symptoms such as a headache or runny nose. High cholesterol can be detected only with a blood test, and statin treatment can last years.
The Food and Drug Administration is asking an advisory panel of outside experts to consider if patients can accurately decide for themselves if they are candidates for Mevacor.
The advisory panel is expected to vote later Thursday on whether to recommend approval for nonprescription Mevacor. The FDA will make the final decision but usually follows panel recommendations. Merck said an FDA ruling is expected in the first quarter of 2008.
An estimated 20 million Americans face moderate heart-disease risk and could benefit from a statin, yet just 6 million of them are on treatment, Merck officials said.
Having Mevacor available on drugstore shelves could lure many untreated patients to therapy, said Edwin Hemwall, an official with Merck Research Laboratories.
“Over time it will reduce the risk of a first heart attack and provide a real impact on public health,” Hemwall said.
In a preliminary review released before the panel meeting, FDA reviewers questioned Merck’s studies of patients who read the drug’s proposed label and decided if they should try Mevacor.
In one study, about 30 percent of people with diabetes or a history of heart disease or a stroke wanted to buy Mevacor, FDA reviewers said. The label advised such patients to consult a doctor before use.
GlaxoSmithKline PLC recently acquired exclusive U.S. rights to sell over-the-counter Mevacor in return for undisclosed milestone and royalty payments to Merck.
Prescription Mevacor, known generically as lovastatin, debuted on the U.S. market in 1987. The drug lost patent protection in 2001. An over-the-counter version would receive three years of exclusive marketing time before generic competition could begin.
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