Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) approved Baraclude (entecavir). Baraclude is indicated for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Baraclude is an oral antiviral therapy specifically designed to block the replication of hepatitis B virus (HBV) in the body by interfering with the virus's ability to infect cells. The drug will be available in the United States as early as April 8, 2005, a release said.

"With the approval of Baraclude, Bristol-Myers Squibb will now be able to address another area of significant unmet medical need, building on our growing presence in fighting cancer, HIV/AIDS, schizophrenia and other diseases," said Peter R. Dolan, chairman and chief executive officer. "Baraclude represents the company's fourth new pharmaceutical approved in less than two and a half years, and has the potential to help many adult patients with chronic hepatitis B infection. Developed in our own laboratories, Baraclude is an important step forward for patients and our company, as we seek to realize our mission of extending and enhancing human life by focusing on discovering, developing and providing innovative treatments for serious diseases."

"In clinical trials, Baraclude demonstrated greater levels of viral suppression compared to lamivudine after 48 weeks of treatment," said Robert Gish, M.D., medical director of the California Pacific Medical Center's Liver Transplant Program. "With today's FDA approval of Baraclude, physicians have an important new medication to treat chronic hepatitis B."

Chronic hepatitis B infection is a potentially life-threatening disease. More than half a million people worldwide die each year from primary liver cancer, and up to 80 percent of primary liver cancers are caused by chronic hepatitis B. In the United States, more than one million people have developed chronic hepatitis B infection and more than 5,000 Americans die from hepatitis B and hepatitis B-related liver complications each year.

"Despite these alarming statistics, it is estimated that only a small percent of diagnosed chronic hepatitis B patients in the U.S. are currently receiving treatment for their disease," said Timothy Block, Ph.D., president, Hepatitis B Foundation and professor, Drexel Medical College. "The availability of Baraclude (entecavir) is an important development that provides a new option for therapy."

Baraclude is a nucleoside analogue with a recommended dosage of a single 0.5-milligram tablet once-daily for chronic hepatitis B patients beginning treatment for the first time (nucleoside-naïve patients), and a single 1-milligram tablet once-daily for patients experiencing resistance to lamivudine (lamivudine-refractory patients).

The Baraclude clinical trial program was the largest-ever conducted in chronic hepatitis B, and the first to compare two antivirals, Baraclude versus lamivudine (the most commonly used oral antiviral therapy for the treatment of chronic hepatitis B worldwide). In these studies after 48 weeks, Baraclude demonstrated statistically significant improvements compared to lamivudine in liver histology, HBV viral load reductions to undetectable levels (defined as less than 300 copies/mL) and normalization of alanine aminotransferase (ALT) levels (less than or equal to 1 times the upper limit of normal), a measure used to determine the degree of liver damage.

In these studies, Baraclude demonstrated comparable safety to lamivudine with a favourable resistance profile. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Baraclude and lamivudine. The most common side effects of Baraclude in clinical studies were headache, tiredness, dizziness, and nausea. Cross resistance has been observed among HBV nucleoside analogues. Lamivudine-resistant patients may not respond as well as nucleoside-naïve patients to Baraclude therapy.

Baraclude (entecavir) is a prescription medicine for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Baraclude does not cure HBV or stop the spread of HBV to others. People should not take Baraclude if they are allergic to it or any of its ingredients. Baraclude has not been studied in children and is not recommended for anyone less than 16 years of age.