Indications -- Hepatitis Message Board

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Biotech / Medical : Indications -- Hepatitis

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To: tuck who wrote (87)	1/25/2005 6:47:52 PM
From: zeta1961	Read Replies (1) of 312

Bristol Entecavir Hepatitis Therapy Slated For Antiviral Cmte. Review [BMY seems to be cranking with new products] FDA’s Antiviral Drugs Advisory Committee will discuss Bristol-Myers Squibb’s oral hepatitis agent entecavir March 11. The committee is slated to review the firm’s NDAs for tablets and an oral solution of the nucleoside analogue for treatment of chronic hepatitis B infection. Bristol announced its submission of entecavir Oct. 4, 2004. The application is receiving a six-month priority review. A European submission is also pending. Results from Bristol’s Phase III trials comparing entecavir to lamivudine (GlaxoSmithKline’s Epivir-HBV) showed significantly greater improvements in liver histology and reductions of HBV DNA levels for entecavir. Roche filed a Pegasys (interferon alfa-2a) sBLA for chronic HBV in July 2004 based on similarly designed studies.

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