USFDA approves Bristol-Myer’s entecavir for chronic hepatitis B

EPP News Bureau - Mumbai

Bristol-Myers Squibb announced that the US Food and Drug Administration (FDA) has approved entecavir – 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, according to a press release.

The release further explained that the drug will be available in the United States this month. Bristol-Myers Squibb is actively working to bring entecavir to the Asia Pacific region, where 75 per cent of the world’s 400 million chronically infected hepatitis B patients live.

‘‘With the approval of entecavir, 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.

‘‘Entecavir 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, entecavir is an important step forward for patients and our company, as we seek to realise our mission of extending and enhancing human life by focusing on discovering, developing and providing innovative treatments for serious diseases,’’ he said.

‘‘In clinical trials, entecavir demonstrated greater levels of viral suppression compared to lamivudine after 48 weeks of treatment,’’ said Robert Gish, MD, medical director of the California Pacific Medical Centre’s Liver Transplant Programme. ‘‘With the FDA approval of entecavir, 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 per cent of primary liver cancers are caused by chronic hepatitis B, the release said.