Idenix and Novartis seek European approval for hepatitis B drug

This application to the European Agency for the Evaluation of Medical Products (EMEA) is the second in a series of submissions aimed at obtaining marketing approvals for telbivudine, an orally active, once-daily nucleoside analogue. A new drug application was recently submitted to the FDA, and Novartis expects to submit applications for marketing authorization in key Asian markets during the first quarter of 2006.

“This submission with the EMEA is another significant step in the development of telbivudine, a drug with the potential to improve the management of chronic hepatitis B, a disease with potentially fatal consequences that affects millions of people around the globe,” said Jean- Pierre Sommadossi, chairman and CEO of Idenix.

The applications for marketing approval are primarily based on an ongoing study comparing telbivudine with a standard therapy, lamivudine, in the treatment of 1,367 adults with chronic hepatitis B.