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
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.