A European Medicines Agency (EMA) expert committee has issued a positive opinion of GlaxoSmithKline’s Cervarix.
The EMA panel’s positive conclusion was based on data from clinical trials of Cervarix involving the vaccination of girls and women between the ages of 10 and 25 years old.
Recommendations for marketing approval by the EMA’s Committee for Medicinal Products for Human Use are usually endorsed by the European Commission within a few months.
Glaxo hopes to launch Cervarix in Europe in the second half of 2007.
Cervarix is not likely to go on sale in the US until 2008, since Glaxo’s FDA submission for the drug was not submitted until this March.
Cervarix won its first major approval in Australia in May.
Pending US and European approval, Cervarix faces competition in the form of Merck’s Gardasil. Analysts have predicted that both drugs have multibillion-dollar-per year potential, with Gardasil having an early edge reaching the market in 2006.
