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news.US biopharmaceutical company Idenix has received regulatory approval to market hepatitis B treatment Sebivo in the EU, triggering a milestone payment from Novartis which is co-promoting the drug.
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Idenix plans to launch the once-a-day oral treatment for adult patients with chronic hepatitis B in the second quarter of 2007 beginning with the UK and Germany. In addition to the European Union, Sebivo is currently approved in more than 15 major markets, including the US, where it is marketed as Tyzeka, Canada, Switzerland and China.
Thierry Poynard of Hopital Pitie-Salpetriere, University of Paris VI, France, investigator in the phase III study, said: “There is no cure for chronic hepatitis B. High hepatitis B viral load increases the risk of serious complications. To reduce this risk, the goal of therapy is to suppress the hepatitis B virus as much as possible, and to maintain that decrease over time.”
The regulatory approval was based on data from a study comparing Sebivo to GlaxoSmithline’s Epivir, a commonly used anti-viral therapy for the treatment of hepatitis B.