Baraclude entecavir regulatory update

The European Commission approved an updated label for Bristol-Myers' Baraclude entecavir to include data on liver transplant recipients with chronic HBV infection. Baraclude is approved in the EU to treat chronic HBV infection in adults with decompensated liver disease and with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation and/or fibrosis. The updated label includes data from the single-arm, open-label Phase IIIb EVT-109 trial in 61 evaluable patients that showed 0% of patients had HBV recurrence defined as serum HBV DNA levels of >=50 IU/mL at week 72, the primary endpoint, following liver transplant and treatment with once-daily 1 mg Baraclude (see BioCentury, April 16). ...