Novartis says that the European Commission has approved Sebivo (telbivudine), a new once-a-day oral treatment for adult patients with chronic hepatitis B and evidence of viral replication and active liver disease.
The Swiss drugmaker says that launches are expected to start in the second quarter of 2007 beginning with the UK and Germany, triggering a milestone payment to the USA’s Idenix and this latest approval is in addition to getting the go-ahead in the USA, where it is marketed as Tyzeka, Canada, Switzerland and China.
The approvals 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 which compared telbivudine to lamivudine. Analysts have suggested the Swiss firm's drug could achieve annual sales of around $400 million or more at peak.
EU committee favours Optaflu
The EU go-ahead for Sebico comes days after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for its influenza vaccine Optaflu.
The cell culture-derived Optaflu is the first influenza vaccine to use a mammalian cell line, rather than chicken eggs, for antigen production. "Optaflu contributes to meeting the growing demand for seasonal influenza vaccines, and this production technology offers the potential for quick scale-up of manufacturing in the event of an influenza pandemic," said Joerg Reinhardt, head of Novartis vaccines. A submission for US regulatory approval for the drug is anticipated in 2008, the company added.