Baraclude receives EC approval for hep B

US pharmaceutical major Bristol-Myers Squibb says that the European Commission has approved its drug Baraclude (entecavir) for the treatment of chronic hepatitis B infection. The product is indicated for chronically-infected adults with compensated liver disease, who also display evidence of active viral replication and persistently high levels of aminotransferases.

The drug has demonstrated the ability to slow the progression of infection in three clinical studies that enrolled both treatment-naive patients and those resistant to lamivudine. In addition, the study program revealed that no resistance to the product emerged after 96-weeks of treatment, and that it had a tolerability profile similar to other commercially-available treatments.

The firm added that it intends to make the product available in some countries in the European Union, the Middle east and Africa by the third quarter of the year.