Idenix Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation have submitted a new drug application (NDA) to the US Food and Drug Administration seeking marketing approval for the 600 mg dose of telbivudine for the treatment of chronic hepatitis B.
This NDA is the first marketing approval submission for telbivudine, an oral, once daily nucleoside analog. Additional applications for marketing authorisation in the European Union (EU) and key Asian markets are expected to be submitted by Novartis Pharma AG in 1Q 2006, claims a company release.
The NDA submission is primarily based on one-year data from the GLOBE study, the largest registration trial for a chronic hepatitis B treatment and the first global trial to include clinical sites and patients in mainland China. The GLOBE study is an ongoing two-year phase III clinical trial comparing telbivudine with a standard therapy, lamivudine, in 1,367 adults with chronic hepatitis B from 112 clinical centres in 20 countries worldwide.
The US FDA has up to 60 days to review an NDA submission prior to accepting it for filing.
The Centres for Disease Control and Prevention (CDC) estimates that 1.25 million Americans are chronically infected with hepatitis B, the most common serious liver infection in the world that can cause liver failure, cirrhosis (scarring), liver cancer and death.
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. The collaboration arrangement further provides that Novartis Pharma AG and Idenix will co-promote telbivudine and valtorcitabine and other product candidates that Novartis Pharma AG has licensed, if successfully developed and approved for marketing, in the United States, France, Germany, Italy, Spain and the UK.
Idenix Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases.