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news.Idenix and Novartis are seeking FDA marketing approval for a 600mg dose of their co-developed drug telbivudine for the treatment of chronic hepatitis B.
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The new drug application is primarily based on one-year data from the GLOBE study, 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.
This new drug application is the first marketing approval submission for telbivudine, an oral, once-daily nucleoside analog. Additional applications for marketing authorization in the European Union and key Asian markets are expected to be submitted by Novartis Pharma AG in the first quarter of 2006.
“This marks a significant step in our company’s growth and in the pursuit of our goal of building a leading antiviral franchise,” said Jean-Pierre Sommadossi, chairman and CEO of Idenix.