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news.An FDA advisory committee has unanimously recommended approval of Bristol-Myers Squibb's investigational oral hepatitis B antiviral Baraclude.
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Baraclude (entecavir) is an investigational oral antiviral agent that selectively inhibits the hepatitis B virus. Bristol-Myers Squibb submitted a new drug application (NDA) to the FDA for Baraclude on September 29, 2004, and was granted a six-month priority review.
The FDA advisory committee reviewed data from the Baraclude clinical development program, the largest and first actively controlled trials of antivirals in chronic hepatitis B. The trials were designed to compare Baraclude to the most commonly used oral antiviral therapy in the US, lamivudine (GlaxoSmithKline’s Epivir), in adult patients with both chronic hepatitis B infection and evidence of active liver inflammation.
The phase III trial program included more than 1,500 patients in three major studies, in which Baraclude demonstrated significant histological improvement and significantly reduced viral load versus lamivudine, with a similar safety profile, at 48 weeks.