More than half a million people worldwide die each year from primary liver cancer, and up to 80 percent of liver cancers are caused by chronic hepatitis B.

The company presented pre-clinical and clinical data to the panel, and discussed plans for a long-term efficacy and safety program. The FDA is not bound by the committee's recommendations, however.

Comparison with Lamivudine

Baraclude selectively inhibits the hepatitis B virus, according to Bristol-Myers Squibb. The company submitted a new drug application 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 FDA Advisory Committee reviewed data from the Baraclude clinical development program, which included 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 program. A variety of different patients with chronic hepatitis B infection were studied, including both HBeAg-positive and HBeAg-negative nucleoside-naive patients and lamivudine-refractory patients.

Significant Improvement Demonstrated

The Phase III trial program included more than 1,500 patients in three major studies: one compared the investigational agent Baraclude to treatment with lamivudine in nucleoside-naive, HBeAg-positive chronic hepatitis B patients; another compared Baraclude to lamivudine in nucleoside-naive patients with HBeAg-negative chronic hepatitis B; and a third study evaluated patients with lamivudine-refractory HBeAg-positive chronic hepatitis B who were either switched directly to Baraclude or continued to receive lamivudine.

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

In these three studies, the most common adverse events of moderate to severe intensity that occurred in greater than or equal to 1% of patients treated with Baraclude were headache, fatigue, diarrhea and dyspepsia.

Background Information on Chronic Hepatitis B

Chronic hepatitis B is a potentially life-threatening viral infection that may lead to cirrhosis, liver failure and liver cancer. The Department of Health and Human Services recently added hepatitis B to its list of known human carcinogens.

More than half a million people worldwide die each year from primary liver cancer, and up to 80 percent of liver cancers are caused by chronic hepatitis B.

In the United States, 12 million people (one out of 20) have been infected at some time in their lives with the hepatitis B virus, and more than five thousand Americans die from hepatitis B-related liver complications each year.

Of those individuals, more than one million people in the U.S. have developed chronic hepatitis B infection. These chronically infected persons are at highest risk of death from liver scarring (cirrhosis) and liver cancer.