Regulatory

Bristol-Myers hepatitis drug impressive - US panel

Last Updated: 2005-03-11 16:16:01 -0400 (Reuters Health)

GAITHERSBURG, Md. (Reuters) - 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 disease in adults.

The advisory panel voted unanimously to support the drug, 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.

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.