U.S. Food and Drug Administration Approves BARACLUDE® (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease
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Viral load reduction at 48 weeks in difficult-to-treat chronic hepatitis B patient population
Viral load reduction at 48 weeks in difficult-to-treat chronic hepatitis B patient population
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At 48 weeks, 57 percent (57/100) of patients treated with BARACLUDE achieved an undetectable viral load compared to 20 percent (18/91) of patients who received adefovir1
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At 48 weeks, 57 percent (57/100) of patients treated with BARACLUDE achieved an undetectable viral load compared to 20 percent (18/91) of patients who received adefovir1
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PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease. 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.
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This new approval is based on virologic, biochemical, serologic, and safety data from a controlled, ongoing, open-label Phase IIIb study (ETV-048). This study compares BARACLUDE (1 mg once daily) to adefovir (10 mg once daily) in CHB patients with decompensated liver disease. Data demonstrated that BARACLUDE was effective in this patient population. BARACLUDE showed greater viral suppression compared to adefovir at 48 weeks following treatment initiation.
“This additional indication for BARACLUDE is important news as it is now proven to be an effective treatment option for physicians to help in managing chronic hepatitis B patients with decompensated liver disease,” said Dr. Naoky Tsai, MD, professor of medicine at the John A.
This new approval is based on virologic, biochemical, serologic, and safety data from a controlled, ongoing, open-label Phase IIIb study (ETV-048). This study compares BARACLUDE (1 mg once daily) to adefovir (10 mg once daily) in CHB patients with decompensated liver disease. Data demonstrated that BARACLUDE was effective in this patient population. BARACLUDE showed greater viral suppression compared to adefovir at 48 weeks following treatment initiation.
“This additional indication for BARACLUDE is important news as it is now proven to be an effective treatment option for physicians to help in managing chronic hepatitis B patients with decompensated liver disease,” said Dr. Naoky Tsai, MD, professor of medicine at the John A.
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