Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Bristol-Myers Squibb Company (BMS) has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) of Baraclude for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.
Subscribe to our email newsletter
Baraclude 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 (ALT or AST) or histologically active disease.
FDA has granted approval based on the virologic, biochemical, serologic and safety data from a controlled, ongoing, open-label Phase IIIb study (ETV-048), which compares Baraclude (1mg once daily) to adefovir (10mg once daily) in CHB patients with decompensated liver disease.
Reportedly, in the study Baraclude was effective in this patient population and the drug also showed greater viral suppression compared to adefovir at 48 weeks following treatment initiation.
John A Burns School of Medicine at the University of Hawaii, Honolulu professor of medicine Naoky Tsai said that the additional indication for Baraclude is important news as it is proven to be an effective treatment option for physicians to help in managing chronic hepatitis B patients with decompensated liver disease.