Cervarix given EU marketing authorisation

GlaxoSmithKline's (GSK's) cervical cancer drug Cervarix has been granted a marketing authorisation for all 27 EU member states, as well as Iceland, Norway and Liechtenstein, putting it head to head with Merck's vaccine Gardasil.

It is reported that GSK will begin marketing Cervarix in Europe in the next few weeks, but the price of the drug is unknown. Gardasil is priced at GBP 80.50 for a 0.5 ml shot, with treatment involving three doses.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2007 based on a review of data from clinical trials which involved almost 30,000 females and which demonstrated good efficacy and immunogenicity data.

Cervarix has been shown to be 100 per cent effective in preventing infection with HPV strains 16 and 18, which together cause about 70 per cent of cervical cancer cases.

Europe is the latest region after Kenya, Australia and the United Arab Emirates to approve marketing of Cervarix.

Cervarix became available in Kenya at the beginning of September 2007 after the country's Pharmacy and Poison's Board approved it for marketing.

GSK is awaiting approval from the US Food and Drug Administration (FDA) approval after submitting its application to the FDA in April 2007. Cervarix will not be on the US market until some time in 2008 after it was refused a fast track six month review. The drug is currently undergoing a 10-month standard review.

Cervarix is formulated with an adjuvant system called AS04, which is designed to enhance the immune response and increase the duration of protection against cancer-causing virus types.

Analysts have projected peak annual sales of USD 2.5bn for Gardasil and USD 1.5bn in peak annual sales for Cervarix.