GlaxoSmithKline (GSK) has announced that its cervical cancer candidate vaccine Cervarix received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the prevention of precancerous lesions (high grade cervical intraepithelial neoplasia - CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus types 16 and 18. This proposed indication is based on data generated in girls and women aged between 10 and 25.

The positive opinion was reached after the CHMP reviewed data from clinical trials in almost 30,000 females, including data from the largest phase III cervical cancer vaccine efficacy trial to date, which demonstrated that the candidate vaccine showed an excellent efficacy profile and was generally well tolerated.

"Today's positive opinion from the CHMP is great news for women across Europe. It is a significant step towards achieving our ambition - to provide women with protection against cervical cancer. Coupled with the excellent clinical trial results published recently, this news is further evidence of the great potential of our cervical cancer candidate vaccine," said JP Garnier, CEO of GSK.

The GSK's cervical cancer candidate vaccine will now be proposed for final approval by the European Commission and a marketing authorisation could be granted in the coming months.

To date, over 40,000 women have participated or are currently taking part in clinical trials to evaluate the efficacy and immunogenicity of GSK's cervical cancer candidate vaccine. In completed clinical trials, GSK's cervical cancer candidate vaccine has been shown to be generally well-tolerated.

GSK's cervical cancer candidate vaccine is formulated with a novel proprietary adjuvant system called AS04, which is designed to enhance the immune response and increase the duration of protection against cancer-causing virus types. Duration of protection is particularly important as women may acquire infections throughout their lifetimes. Published data have shown that the vaccine formulated with this adjuvant system induces an immune response of higher magnitude and persistence compared to a GSK vaccine formulated with conventional aluminum hydroxide adjuvant alone.

Following its first licence in a major market granted by the Therapeutic Goods Administration (TGA) of Australia, Cervarix is now available in Australia for the prevention of cervical cancer and precancerous lesions caused by human papillomavirus types 16 and 18 for use in females age 10 to 45 years.

GSK submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for GSK's cervical cancer candidate vaccine in March 2007, following earlier regulatory filings in Africa, Asia and Latin America.