Idenix and Novartis submit hep B drug to FDA

USA-based pharmaceutical firm Idenix and Swiss group Novartis say they have submitted a New Drug Application to the Food and Drug Administration seeking marketing approval for telbivudine, specifically at the 600mg dosage, for the treatment of chronic hepatitis B infection. The two firms entered into an R&D agreement in May 2003, which covers the co-development and commercilization of the hepatitis B product candidates telbivudine and valtorcitabine.

The NDA is based on one year of data from the ongoing Globe Phase III hepatitis B study which has enrolled 1,367 adult sufferers at 112 clinical centers around the world (Marketletter August 8, 2005). Novartis is expected to seek further marketing authorizations, particularly in the European Union, in the first quarter of 2006.