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Swiss pharmaceutical firm Novartis says the European Commission hasapproved its drug Sebivo® (telbivudine), a new once-daily oraltreatment for adults with chronic hepatitis B and evidence of viralreplication and active liver disease.
The firm sayslaunches are expected to start in the second quarter of 2007, initiallythe UK and Germany. This latest approval is in addition to getting thego-ahead in the USA (where the drug is marketed as Tyzeka), Canada,Switzerland and China.
The approvals have been based mainlyon one-year data from the GLOBE study, the largest worldwideregistration trial including hepatitis B e-antigen (HBeAg)-positive andHBeAg-negative patients, which compared telbivudine to lamivudine.
TheEU go-ahead for Sebivo comes days after the EMEA committee formedicinal products for human use recommended approval for Novartis’sinfluenza vaccine Optaflu®.
The cell culture-derivedOptaflu is said to be the first influenza vaccine to use a mammaliancell line, rather than chicken eggs, for antigen production. JoergReinhardt, head of Novartis vaccines, said: “Optaflu contributes tomeeting growing demand for seasonal influenza vaccines, and thisproduction technology offers the potential for quick scale-up ofmanufacturing in the event of an influenza pandemic.” Submission for USregulatory approval is anticipated in 2008.