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Bristol-Myers Hepatitis Drug Impressive – FDA Panel

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U.S. health experts on Friday praised the effectiveness of Bristol-Myers Squibb Co.’s experimental hepatitis B drug and recommended the Food and Drug Administration approve it to treat the liver disease in adults.

The scientific panel voted unanimously to support the drug, known by its chemical name entecavir, saying data showed it was superior to other available medicines. The FDA usually follows the advice of its advisory panels. “I’m impressed by what I’ve seen today,” said panelist Lynn Paxton of the Centers for Disease Control and Prevention. Hepatitis B, which is spread through contact with body fluids like blood, is an inflammation of the liver that can lead to liver scarring and even death. Company officials told the panelists that data from clinical trials showed entecavir was more potent than other approved hepatitis drugs, including GlaxoSmithKline Plc’s Epivir and Gilead Sciences Inc.’s Hepsera. It was also stronger than rival hepatitis drug telbivudine, which is being developed by Novartis AG and Idenix Pharmaceuticals Inc., Bristol officials said. Shares of Bristol-Myers were unchanged at $24.87 in afternoon trade on the New York Stock Exchange. (Source: Reuters Health, March 2005)

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Dates

Posted On: 13 March, 2005
Modified On: 16 January, 2014


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