Novartis and Idenix Pharmaceuticals seek European approval for telbivudine (LTD600) 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 Europe and over 350 million people worldwide.
The European submission, done through the centralised procedure to the Committee for Medicinal Products for Human Use (CHMP), is the second in a series aimed at obtaining approvals for telbivudine (600 mg dose) as an orally active, once-daily nucleoside analogue. Telbivudine was recently filed with the US Food and Drug Administration for approval. Novartis expects to submit applications for approval in key Asian markets during the first quarter of 2006, informs the company release.
"Telbivudine has shown the potential to set a standard of care for the treatment of patients with hepatitis B through rapid and sustained viral suppression. The European filing is a significant step toward making this new treatment option available to more than three million patients estimated to be affected by the chronic hepatitis B virus in Europe," said Dr. James Shannon, global head of development, Novartis Pharma AG.
The European submission was based primarily on one-year data from the GLOBE study, the largest registration trial for a chronic hepatitis B treatment. The GLOBE study is an ongoing two-year phase III clinical trial comparing telbivudine with a standard therapy, lamivudine, in the treatment of 1,367 adults with chronic hepatitis B. The study is being conducted at 112 clinical centres in 20 countries worldwide.
Idenix is developing its hepatitis B clinical product candidates, telbivudine and valtorcitabine, in collaboration with Novartis Pharma AG under a development and commercialisation arrangement established in May 2003.