Bristol-Myers Squibb has received approval from the US Food and Drug Administration for Baraclude, a nucleoside analogue for the treatment of chronic hepatitis B in adults with decompensated liver disease.
The approval is based on serologic, virologic, biochemical and safety data from a controlled, ongoing and open-label Phase IIIb study, which compares Baraclude 1mg once daily with adefovir 10mg once daily.
Results indicated that Baraclude was effective in this patient population and that the drug demonstrated greater viral suppression than adefovir at 48 weeks after the initiation of the treatment.
At 48 weeks, about 57% of the patients who received Baraclude achieved an undetectable viral load, compared with 20% of patients who received adefovir.
Chronic hepatitis B is a serious viral infection which results in liver damage and is estimated to affect around 1.25 million people in the US.