EC approves Sebivo for chronic HBV

The European Commission has approved Sebivo (telbivudine), a new once-a-day pill for adult patients with chronic hepatitis B (CHB) with evidence of viral replication and active liver disease. Novartis and USA-based Idenix expect to launch their co-developed drug in the second quarter of the year, beginning with the UK and Germany.

The approval of Sebivo in Europe triggers an undisclosed milestone payment to Idenix. In addition to the European Union, Sebivo is currently approved in more than 15 major markets, including the USA, where it is sold as Tyzeka (telbivudine), Canada, Switzerland and China. Worldwide regulatory submissions have been based primarily on one-year data from the GLOBE study, the largest worldwide registration trial including hepatitis B e-antigen (HBeAg)-positive and HBeAg-negative patients with CHB. The two companies are co-promoting the agent for the treatment of chronic hepatitis B, and co-developing the HBV drug valtorcitabine and valopicitabine, a treatment for hepatitis C, under a development and commercialization arrangement signed in May 2003.