Panel urges approval of new hepatitis B drug

updated 6:12 p.m. ET March 11, 2005

WASHINGTON - A Food and Drug Administration advisory committee on Friday urged approval of a new drug for the treatment of chronic hepatitis B, the drug manufacturer said.

The drug, entecavir, is taken orally and is designed to work by preventing the virus that causes the illness from reproducing.

The advisory committee recommended approval despite studies indicating an increase in cancer in mice administered the drug. In studies in humans the main side effects were headache, diarrhea, fatigue and upset stomach, the company reported.

The chronic form of hepatitis B can damage permanently the liver and lead to cirrhosis and liver cancer.

Entecavir, made by Bristol-Myers Squibb, will be sold under the trade name Baraclude if it gets FDA approval. The agency isn’t required to follow the recommendations of its advisory committees, though it generally does so.

Current treatment options for chronic hepatitis include the drugs interferon, given by injection, and two drugs administered orally, lamivudine and adefovir dipivoxil.

The Hepatitis B Foundation estimates that 1.2 million Americans have hepatitis B and another 100,000 are infected annually.

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