BARACLUDE(R) (entecavir) Approved by the European Commission for the Treatment of Chronic Hepatitis B in Adult Patients

Publicado el 01 marzo 2011 por Fat
Bristol-Myers Squibb announced today that BARACLUDE(R) (entecavir) has been approved by the European Commission on February 28th 2011 to treat chronic hepatitis B (CHB) in adult patients with evidence of decompensated liver disease.
BARACLUDE(r) was already approved in Europe in June 2006 for use in adult patients with CHB with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
This approval grants BARACLUDE(r) marketing authorisation in the 27 countries of the European Union. In the U.S., the Food and Drug Administration (FDA) approved the decompensated indication for BARACLUDE(r) in October 2010.
Decompensated liver disease is characterised by failure of the liver to maintain adequate function, usually due to severe scarring, leading to fibrosis and/or cirrhosis caused by chronic liver inflammation. It represents the end stage of hepatitis. Natural history data demonstrate that up to 40% of patients with CHB develop cirrhosis over their lifetimes, at a reported rate of 2-6% per year. Among CHB patients with cirrhosis, 3-5% per year progress to decompensated cirrhosis and 2-5% develop hepatocellular carcinoma (HCC). Currently, the median survival rate in decompensated patients is two to three years, with only 28% of patients surviving for more than five years. Once liver disease progresses to the decompenstated stage, a liver transplant is often necessary.
"The approval of this additional indication is an important milestone for CHB patients living with decompensated liver disease, a difficult to treat population whose mortality rates are high," said Professor Jorg Petersen. "The data used to support this indication shows that BARACLUDE(r) is efficacious in treating decompensated patients."
This approval is based on a randomised, open-label, multi-centre study (ETV-048) that compared the efficacy & safety of BARACLUDE(r) (1.0 mg once daily) with adefovir (10.0 mg once daily) administered in patients with HBeAg positive or negative CHB who had evidence of liver decompensation.
Data demonstrated that BARACLUDE(r) showed greater viral suppression compared to adefovir at 24 and 48 weeks following treatment initiation. At 48 weeks, 57% (57/100) of patients treated with BARACLUDE(r) achieved an undetectable viral load (less than or equal to 300 copies/ml) compared to 20% (18/91) of patients on adefovir.

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