EAST HANOVER, N.J. Idenix Pharmaceuticals, Inc. and Novartis Pharmaceuticals Corporation announced today that a New Drug Application (NDA) was submitted to the United States Food and Drug Administration (FDA) seeking marketing approval for the 600 mg dose of telbivudine for the treatment of chronic hepatitis B.Â This NDA is the first marketing approval submission for telbivudine, an oral, once-daily nucleoside analog.Â Additional applications for marketing authorization in the European Union (EU) and key Asian markets are expected to be submitted by Novartis Pharma AG (an affiliate of Novartis Pharmaceuticals Corporation) in 1Q 2006.
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.Â 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 centers in 20 countries worldwide.
The FDA has up to 60 days to review an NDA submission prior to accepting it for filing.
The Centers for Disease Control and Prevention (CDC) estimates that 1.25 million Americans are chronically infected with hepatitis B(1), the most common serious liver infection in the world that can cause liver failure, cirrhosis (scarring), liver cancer and death.(2)
Chronic hepatitis B is caused by the hepatitis B virus (HBV), which infects the liver.(2)Â HBV is 50-to-100 times more infectious than HIV (the virus that causes AIDS).(3)Â Chronic hepatitis B is the 10th leading cause of death worldwide.(4)Â It affects approximately 350 million people worldwide and is responsible for up to 80 percent of the world's primary liver cancer.(5) Each year approximately 1.2 million people worldwide die from hepatitis B-related chronic liver disease.(4)
Despite the availability of treatments for chronic hepatitis B, significant unmet needs still exist including the need for improved response rates, better-long-term efficacy, reduced rates of drug resistance, improved safety and tolerability, and more convenient dosing regimens.
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