INDIANAPOLIS (AP) -- Drugmaker Bristol-Myers Squibb Co. said Monday federal regulators have approved its hepatitis B treatment Baraclude for patients with a more severe form of liver disease.
The Food and Drug Administration approved the New York company's application to treat chronic hepatitis B in adult patients with decompensated liver disease, which involves the liver failing to perform properly often due to severe scarring.
The treatment was first approved in March 2005 to treat patients with compensated liver disease, where the liver is damaged but can still perform.
Bristol-Myers said Baraclude showed greater viral suppression in patients when compared with adefovir in a late-stage study.
About 1.3 million Americans are infected with a chronic form of hepatitis B.
Bristol-Myers shares fell 8 cents to $27.12 in Monday afternoon trading.
The Food and Drug Administration approved the New York company's application to treat chronic hepatitis B in adult patients with decompensated liver disease, which involves the liver failing to perform properly often due to severe scarring.
The treatment was first approved in March 2005 to treat patients with compensated liver disease, where the liver is damaged but can still perform.
Bristol-Myers said Baraclude showed greater viral suppression in patients when compared with adefovir in a late-stage study.
About 1.3 million Americans are infected with a chronic form of hepatitis B.
Bristol-Myers shares fell 8 cents to $27.12 in Monday afternoon trading.
