Cervical Cancer :: Cervarix, GSK’s cervical cancer vaccine, approved in Europe

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 precancerous 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 isbased on data generated in girls and women aged between 10 and 25.

“The decision to approve Cervarix for the European U nion represents a great step forward for European women. Physicians across Europewill now have access tothis important vaccine to help protect women against cervical cancer, the second most common cancer in women,” said JP Garnier, Chief Executive Officer of 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.

The file included:

· Data from the largest Phase III cervical cancer vaccine efficacy trial to date3, which demonstrated that – based on a post hoc analysis – Cervarix provides 100 percent protection against precancerous 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.4 The trial also indicated that CervarixTM is generally well tolerated.

· Long-term trial data showing CervarixTM provides 100 percent sustained protection for up to 5.5 years after vaccination.1 Duration of protection is particularlyimportant 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.

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