Bristol-Myers Squibb receives FDA expanded approval for Baraclude

Bristol-Myers Squibb on Monday announced that the FDA approved a new indication for Baraclude (entecavir) for the treatment of patients with chronic hepatitis B (CHB) with decompensated liver disease.
The approval was based on data from an ongoing Phase IIIb clinical trial that found that in this patient population, Baraclude, after 48 weeks, showed greater viral suppression compared to adefovir.
Baraclude was approved by US and EU regulators in 2005 and 2006, respectively, as a treatment for patients with chronic hepatitis B with compensated liver disease.
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Reference Articles
U.S. Food and Drug Administration approves Baraclude (entecavir) as a treatment for chronic hepatitis B patients with evidence of decompensated liver disease - (Bristol-Myers Squibb)
Bristol-Myers Squibb says FDA approves Baraclude - (Stock Markets Review)
FDA OKs expanded use for Bristol-Myers' Baraclude - (Yahoo!Finance)

**Published in "First Word"