FDA approves new drug to treat hepatitis B

Bristol-Myers Squibb announced this week that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for Baraclude,to treat chronic hepatitis B in adults with liver disease.

Baraclude uses the nucleotide analogue entecavir, which was first approved by the FDA in 2005 for treating chronic hepatitis B in adults with liver disease, reports.

BMS officials told that the approval was based on virologic, biochemical, serologic and safety data from a controlled, ongoing, open-label Phase IIIb study.

Dr. Naoky Tsai, a professor of medicine at the John A. Burns School of Medicine at the University of Hawaii, Honolulu, told the study compared Baraclude to adefovir.

Baraclude was administered to random patients at a dosage of one milligram daily, while adefovir was given at a dosage of 10 milligram once daily. Tsai said data showed that Baraclude was effective in the patient population and showed a greater viral suppression compared to adefovir following a 48 week 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,” Tsai told

Decompensated liver disease is the failure of the liver to maintain adequate function, often due to severe scarring.