Novartis/Idenix submit telbivudine for EU appro

Swiss drug major Novartis and the USA's Idenix Pharmaceuticals have sumbitted their co-developed drug candidate telbivudine (LTD600) to European regulators for approval as a novel treatment for patients affected by chronic hepatitis B (CHB), a potentially fatal disease estimated to affect more than three million people in the region and over 350 million worldwide.

The submission, made through the European Medicine Agency's Committee for Medicinal Products for Human Use centralized procedure, is the second in a series aimed at obtaining approvals for a 600mg dose of the orally-active, once-daily nucleoside analog. The agent was also recently filed with the US Food and Drug Administration for approval and Novartis expects to submit applications for clearance in key Asian markets during the first quarter.

The companies' submission was based primarily on one-year data from the GLOBE study, the largest registration trial for a CHB treatment, which is an ongoing two-year Phase III program comparing telbivudine with a standard therapy, lamivudine, in the treatment of 1,367 adults with the condition. The firms noted that CHB is the most common serious liver infection in the world, which can cause liver failure, cirrhosis and liver cancer.