The US FDA Antiviral Drugs Advisory Committee has recommended approval of Bristol-Myers Squibb's Baraclude (entecavir), the company's investigational oral antiviral agent under development for the treatment of chronic hepatitis B. The company presented pre-clinical and clinical data, and discussed plans for a long-term efficacy and safety programme. The FDA is not bound by the committee's recommendations.

Baraclude 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 - a status reserved for investigational agents that may address unmet medical needs, the BMS release stated.

The FDA Advisory Committee reviewed data from the Baraclude clinical development programme, 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 United States, lamivudine, in adult patients with both chronic hepatitis B infection and evidence of active liver inflammation. More than 2,300 patients from five continents participated in the Baraclude clinical programme. A variety of different patients with chronic hepatitis B infection were studied, including both HBeAg-positive and HBeAg-negative nucleoside-naïve patients and lamivudine-refractory patients.

Baraclude demonstrated significant histological improvement and significantly reduced viral load versus lamivudine with a similar safety profile in these three studies at 48 weeks.