BMS' Hepatitis B Drug Gets Thumbs Up From FDA Panel

An FDA advisory committee voted unanimously to recommend approval of Bristol-Myers Squibb's (BMS) Baraclude, an investigational oral antiviral agent under development for the treatment of chronic hepatitis B.

The agency's Antiviral Drugs Advisory Committee recommended that Baraclude (entecavir) be approved as a first-line therapy for chronic hepatitis B patients. The committee based its recommendation in part on the results of three clinical studies that showed Baraclude demonstrated significant histological improvement and significantly reduced viral load versus lamivudine with a similar safety profile at 48 weeks.

BMS submitted a new drug application to the FDA for Baraclude Sept. 29, 2004, and was granted a six-month priority review.