European Committee Recommends Approval Of GSK's Experimental HPV Vaccine Cervarix For Sale In E.U. Countries

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology
Article Date: 24 Jul 2007 - 12:00 PDT

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The European Committee for Human Medicinal Products has recommended GlaxoSmithKline's experimental human papillomavirus vaccine Cervarix for sale and marketing in the European Union, the company announced Wednesday, United Press International reports (United Press International, 7/18). According to the AP/International Herald Tribune, the committee reviewed data on the vaccine from clinical trials involving 30,000 women (AP/International Herald Tribune, 7/19).

Cervarix has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. Researchers in a 2006 study published in the online edition of the Lancet also found that Cervarix prevented infection with HPV strains 31 and 45, which together with strains 16 and 18 cause more than 80% of cervical cancer cases.

According to a recent study, Cervarix was 90.4% effective in preventing lesions caused by HPV strains 16 and 18, based on an analysis that only required detection of the virus in the lesion. However, researchers found most of the lesions contained multiple HPV strains known to cause cancer, and GSK said the data showed Cervarix was 100% effective in preventing lesions caused by strains 16 and 18. According to the study, the vaccine also provided significant protection against HPV strains 31, 45 and 52, which together account for about 12% of cervical cancer cases.

The Australian Therapeutic Goods Administration last month granted the first major market license for Cervarix, approving the vaccine for girls and women ages 10 to 45. FDA has granted a standard 10-month review of the vaccine and will most likely take action on GSK's application in January 2008, according to analysts at Evolution Securities (Kaiser Daily Women's Health Policy Report, 6/28). GSK said it expects to receive final marketing approval from the European Commission in the coming months, Dow Jones/CNNMoney.com reports (Berton, Dow Jones/CNNMoney.com, 7/19).

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