Bristol Myers Squibb statement on FDA advisory committee vote on Baraclude (entecavir), an investigational oral antiviral agent for chronic hepatitis B.

(From Chemical Business NewsBase - Press Release)

Bristol Myers Squibb Co announced that the US Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee unanimously recommended approval of Baraclude (entecavir), the company's investigational oral antiviral agent under development for the treatment of chronic hepatitis B. The company presented pre-clinical and clinical data, and discussed plans for a long-term efficacy and safety programme. Baraclude is an investigational oral antiviral agent that selectively inhibits the hepatitis B virus. Bristol Myers Squibb submitted a new drug application to the FDA for Baraclude on 29 Sep 2004, and was granted a …