Bristol-Myers Squibb Company Release: FDA Approves Labeling Update for BARACLUDE® (entecavir) (0.5 mg/1 mg Tablets) to Include Data on African Americans and Liver Transplant Recipients With Chronic Hepatitis B in Adult Patients
Published: Oct 16, 2012
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the labeling for BARACLUDE® (entecavir) to include data on African Americans and liver transplant recipients with chronic hepatitis B infection. BARACLUDE, a nucleoside analogue discovered at Bristol-Myers Squibb, was first approved by the U.S. Food and Drug Administration in March 2005 for use in adult chronic hepatitis B patients with compensated liver disease. BARACLUDE is indicated for the treatment of chronic hepatitis B virus (HBV) 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. The following points should be considered when initiating BARACLUDE: This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease; virologic, biochemical, serologic, and safety data are available from a controlled study in adult patients with chronic HBV infection and decompensated liver disease; virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy. The current labeling update was accepted based on one study in African-American patients and one study in post-liver transplant recipients, each investigating BARACLUDE in these populations.