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FDA Advisory Committee Recommends Approval of Entecavir, Hepatitis B Treatment
PRINCETON, NEW JERSEY (March 11, 2005) --Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee unanimously recommended approval of 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 program. 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.1
"Bristol-Myers Squibb is dedicated to conducting research and developing therapies designed to aid in the fight against serious diseases with significant unmet medical needs, such as chronic hepatitis B infection," said Elliott Sigal, M.D., Ph.D., chief scientific officer and president, Pharmaceutical Research Institute, Bristol-Myers Squibb. "Our global BARACLUDE clinical program spans five continents, and we are committed to advancing treatment for this disease around the world."
BARACLUDE™ Clinical Development Program
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 United States, lamivudine, in adult patients with both chronic hepatitis B infection and evidence of active liver inflammation.2 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-naïve patients and lamivudine-refractory patients.
The Phase III trial program included more than 1,500 patients in three major studies: AI463-022, which compared the investigational agent BARACLUDE to treatment with lamivudine in nucleoside-naïve, HBeAg-positive chronic hepatitis B patients; AI463-027 which compared BARACLUDE to lamivudine in nucleoside-naïve patients with HBeAg-negative chronic hepatitis B; and AI463-026, which 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. In these three studies, the most common adverse events of moderate to severe intensity that occurred in > 1% of patients treated with BARACLUDE were headache, fatigue, diarrhea, and dyspepsia.
Chronic hepatitis B is a potentially life-threatening viral infection that may lead to cirrhosis, liver failure, and liver cancer.3 The Department of Health and Human Services recently added hepatitis B to its list of known human carcinogens.4 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.5
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 year6. Of those individuals, more than one million people in the U.S. have developed chronic hepatitis B infection.6 These chronically infected persons are at highest risk of death from liver scarring (cirrhosis) and liver cancer.7
1 Center for Drug Evaluation and Research. Available at 4 Report on Carcinogens, Eleventh Edition; U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program. Available at http://ntp.niehs.nih.gov/ntp/roc/toc11.html. Accessed March 14, 2005.