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news.Bristol-Myers Squibb has received the European Commission approval for Baraclude (entecavir) as a treatment for chronic hepatitis B (CHB) in adult patients with evidence of decompensated liver disease.
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With this approval Bristol-Myers Squibb get marketing authorization right for Baraclude in 27 countries of the European Union.
According to the company, the approval is based on a randomised, open-label, multi-centre study (ETV-048) that compared the efficacy & safety of Baraclude (1.0mg once daily) with adefovir (10.0mg once daily) administered in patients with HBeAg positive or negative CHB who had evidence of liver decompensation.
In the trial Baraclude demonstrated viral suppression compared to adefovir at 24 and 48 weeks following treatment initiation.
At 48 weeks, 57% (57/100) of patients treated with Baraclude achieved an undetectable viral load (less than or equal to 300 copies/ml) compared to 20% (18/91) of patients on adefovir.