GlaxoSmithKline (GSK) announced that the European Commission has granted a marketing authorisation for its cervical cancer vaccine, Cervarix for all 27 European member states.
Cervarix, with its innovative AS04 adjuvant system, is indicated for the prevention of pre-cancerous cervical lesions (high-grade cervical intraepithelial neoplasia [CIN] grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18. The indication is based on data generated in girls and women aged between 10 and 25, said a company press release.
"The decision to approve Cervarix for the European Union represents a great step forward for European women. Physicians across Europe will now have access to this important vaccine to help protect women against cervical cancer, the second most common cancer in women," said JP Garnier, chief executive officer, GSK.
The approval follows positive opinion of 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 excellent efficacy and immunogenicity data.
Based on a post hoc analysis Cervarix provides 100 per cent protection against pre-cancerous lesions (CIN2+) causally related to human papillomavirus types 16 and 18. These virus types are responsible for 70 per cent of all cervical cancer cases worldwide. The trial also indicated that Cervarix is generally well tolerated.
Long-term trial data showing Cervarix provides 100 per cent sustained protection for up to 5.5 years after vaccination. Duration of protection is particularly important as women may acquire infections throughout their lifetimes. Data from immunogenicity trials, which indicate that Cervarix is highly immunogenic in a broad age range, inducing high antibody levels in women aged 10-55 years old.
Cervarix 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. Published data have shown that Cervarix, formulated with this adjuvant system, induces an immune response of higher magnitude and persistence compared to the same vaccine composition, formulated with conventional aluminium hydroxide adjuvant alone.
Cervarix is indicated in the EU for the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.7. In May 2007, Cervarix was granted its first license in a major market by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and pre-cancerous lesions caused by human papillomavirus types 16 and 18 for use in females ages 10 to 45 years. This is the first time that a cervical cancer vaccine has been approved with an explicit indication anywhere in the world for women over the age of 26. Subsequent licenses have been granted in other international markets.
GSK submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its cervical cancer candidate vaccine in March 2007, following earlier regulatory filings with the European Medicines Agency (EMEA) and regulatory filings in Africa, Asia and Latin America.
Cervical cancer is the second leading cause of cancer in women, and causes over 270,000 deaths worldwide per year. It occurs when infection with the human papillomavirus becomes persistent and progresses to cancer. Up to 80 per cent of sexually active women will acquire a human papillomavirus infection in their lifetime, with the risk of persistence increasing with age.
Approximately 100 types of human papillomavirus have been identified so far and, of these, approximately 15 virus types are considered to cause cervical cancer. Virus types 16 and 18 are responsible for approximately 71.5 per cent of cervical cancers in Europe.