by Medindia Content Team on  July 8, 2006 at 9:22 PM Drug News
India Approves Baraclude™ (entecavir) For 
Treatment Of Chronic HEPATITIS B
Bristol-Myers Squibb has announced the launch of BARACLUDE™ (entecavir) for the treatment of chronic hepatitis B virus infection following its approval by the Drug Controller General of India.

BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus 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 liver.

Chronic hepatitis B infection is a potentially life-threatening disease. More than half a million people worldwide die each year from hepatocellular carcinoma (HCC), and up to 80 percent of these cancers are caused by chronic hepatitis B.

India has intermediate endemicity for hepatitis B infection with prevalence for chronic infection of 4%. An estimated 36 million are chronically infected with the hepatitis B virus, most of which are established during early childhood. Hepatitis B infection is reported to be responsible for 80% of the cases of cirrhosis of the liver and 60% of HCC. It was estimated that 12,750 new cases of HCC were diagnosed in 2001.

'With the approval and launch of BARACLUDE™ in India, Bristol-Myers Squibb will now be able to address another area of significant unmet medical need: chronic hepatitis B,' said Mr Eric Breumier, Managing Director, Bristol-Myers Squibb India.

'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'.

The Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2005 update, states that sustained viral suppression is the key to reduction or prevention of hepatic injury and disease progression and the primary goal of treatment for chronic hepatitis B is to eliminate or permanently suppress the hepatitis B viral load.

Viral load is a key predictor of progression to cirrhosis of the liver and hepatocellular carcinoma. (HCC or liver cancer). The higher the viral load the greater the risk of developing cirrhosis and HCC.

With the availability of BARACLUDE™ physicians have an important new medication to treat chronic hepatitis B by reducing the viral load and the associated risk of developing cirrhosis and liver cancer.

About BARACLUDE™ (entecavir)

Discovered at Bristol-Myers Squibb, BARACLUDE™ is a nucleoside analog, approved for marketing in the United States by the U.S. Food and Drug Administration (FDA) on March 29, 2005.

To date, BARACLUDE™ has been approved in 21 countries including China, Thailand, Singapore, Philippines, Malaysia, Macau, Indonesia, Vietnam, India and Australia in the Asia-Pacific region.

Bristol-Myers Squibb has submitted marketing applications for BARACLUDE™ in other regions and countries around the world, including the European Community, Hong Kong, Pakistan and Taiwan.

The global BARACLUDE™ clinical trial program was the first to compare two antiviral, BARACLUDE™ and lamivudine and involved over 1,600 patients worldwide.

You can visit Bristol-Myers Squibb on the World Wide Web at where you can learn more about BARACLUDE™ (entecavir) and the Full Prescribing Information, including boxed WARNINGS.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

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