New Indication Okayed for Chronic Hepatitis B Drug

Bristol-Myers Squibb of Princeton, N.J., has received FDA approval to market Baraclude (entecavir) as a treatment for chronic hepatitis B (CHB) patients with evidence of decompensated liver disease. The drug 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 or histologically active disease.

Entecavir, which is a nucleoside analogue, was first approved in March 2005 for use in adult CHB patients with compensated liver disease. In a study, 57% of patients treated with entecavir achieved an undetectable viral load at 48 weeks compared with 20% of patients who received adefovir, the company said.