11 novembre, 2006 18:40

Merck Seeking Approval For Vioxx Successor

(AP) TRENTON Drugmaker Merck & Co., which has been seeking U.S. approval for a successor to its withdrawn arthritis painkiller Vioxx for nearly three years, has submitted new patient data to regulators and could get a decision on the drug next spring.

The Whitehouse Station-based company said Friday that it has given the U.S. Food and Drug Administration data on Arcoxia that includes results of a large study that focused on whether the arthritis drug increased risk of heart attacks and stroke.

In August, Merck said that preliminary analysis of its data showed Arcoxia didn’t raise risk of heart attack and stroke, compared to an older anti-inflammatory drug, but that more patients taking Arcoxia withdrew from the study due to high blood pressure and fluid retention.

Merck pulled Vioxx, a blockbuster that once was one of its top drugs, from the market in September 2004 after its own research showed Vioxx doubled risk of heart attack and stroke.

The company now faces about 24,000 lawsuits covering about 42,000 plaintiff groups alleging harm, plus hundreds of potential class-action suits claiming personal injury or financial losses.

To date, Merck has reserved about $1.57 billion to cover Vioxx legal costs.

The new study pools the results of three different trials involving a total of more than 34,000 patients.

The results are part of Merck’s response to the FDA, which said in October 2004, the month after Vioxx was pulled from the market, that it needed more data on the safety and efficacy of Arcoxia before it could allow sales.

Arcoxia already is sold in the 62 countries in Europe, Asia and other regions, and had sales totaling $192 million over the first nine months of this year.

Wall Street showed little reaction to the news. In morning trading on the New York Stock Exchange, Merck shares were up 1 cent at $42.89.