European Commission Approves GSK's Experimental HPV Vaccine Cervarix

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HPV Vaccine Cervarix

GlaxoSmithKline on Monday announced that the European Commission has approved the company's experimental human papillomavirus vaccine Cervarix for sale and marketing in the European Union, Reuters reports (Reuters,9/24). Cervarix has been shown to be 100% effective in preventinginfection with HPV strains 16 and 18, which together cause about 70% ofcervical cancer cases.


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

TheEuropean Committee for Human Medicinal Products in July recommendedCervarix for sale and marketing in the European Union. The committeereviewed data on the vaccine from clinical trials involving 30,000women (Kaiser Daily Women's Health Policy Report,7/20). A GSK spokesperson said Cervarix would go on sale in majorEuropean markets shortly. She added, "We intend to launch across Europewithin the next few weeks."

GSK declined to comment on howmuch the company will charge for Cervarix or whether the European pricewould be above or below that in Australia, where the vaccine received regulatory approval in May. The vaccine is not likely to go on sale in the U.S. before 2008, Reuters reports (Reuters, 9/24). The company said a decision on its FDA application for Cervarix's approval in the U.S. will be given in January 2008 (Hofmann, Thomson Financial/Hemscott, 9/24).

"Thedecision (by the European Commission) to approve Cervarix for theEuropean Union represents a great step forward for European women," GSKCEO J.P. Garnier said in a statement. He added, "Physicians acrossEurope will now have access to this important vaccine to help protectwomen against cervical cancer, the second most common cancer in women" (AFP/Yahoo! News, 9/24).

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