Bristol-Myers Squibb Company (BMS) announced that the US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Baraclude 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.
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 Baraclude (1 mg once daily) to adefovir (10 mg 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.
“This additional indication for Baraclude is important news as it is now proven to be an effective treatment option for physicians to help in managing chronic hepatitis B patients with decompensated liver disease,” said Dr Naoky Tsai, professor of medicine at the John A. Burns School of Medicine at the University of Hawaii, Honolulu.
Decompensated liver disease refers to failure of the liver to maintain adequate function, often due to severe scarring of the liver. Chronic hepatitis B infection is commonly associated with chronic liver inflammation and can lead to decompensated liver function.
Baraclude, a nucleoside analogue discovered at Bristol-Myers Squibb, was first approved in March 2005 for use in adult chronic hepatitis B patients with compensated liver disease.