US FDA approves expanded use of Bristol-Myers Baraclude for chronic hepatitis B

The US Food and Drug Administration has approved drug major Bristol-Myers Squibb’s (NYSE: BMY) supplemental New Drug Application (sNDA) of Baraclude (entecavir)  for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease. Baraclude is indicated for the treatment of CHB 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.

B-MS’ drug was first approved in the USA in March 2005, and in July 2006 in Europe, for use in adult chronic hepatitis B patients with compensated liver disease. Second-quarter 2010 sales of the drug leapt 25% year-on-year to $223 million (The Pharma Letter July 23).

This new approval is based on virologic, biochemical, serologic, and safety data from a controlled, ongoing, open-label Phase IIIb study (ETV-048). This study compares (1mg once daily) to adefovir (10mg once daily) in CHB patients with decompensated liver disease. Data demonstrated that Baraclude was effective in this patient population. Baraclude showed greater viral suppression compared to adefovir at 48 weeks following treatment initiation.