GlaxoSmithKline on Thursday announced that it has filed for FDA approval of its experimental human papillomavirus vaccine Cervarix, the Philadelphia Inquirer reports (Ginsberg, Philadelphia Inquirer, 3/30). Cervarix and Merck's HPV vaccine Gardasil have 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. GSK in January announced that it would begin a trial to determine whether Cervarix provides better protection against cervical cancer than Gardasil. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine. According to Merck, Gardasil is about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases. Gardasil also protects against vaginal and vulvar cancers, two other gynecological cancers that are linked to HPV, according to a study presented in June 2006 at a meeting of the American Society of Clinical Oncology in Atlanta (Kaiser Daily Women's Health Policy Report, 1/19).

Application Details
GSK said that its FDA application includes data on HPV strains that cause 70% of cervical cancers worldwide, as well as other strains that can cause cervical cancer. The application had data from clinical trials involving about 30,000 girls and women ages 10 to 55, according to GSK (Reuters UK, 3/29). FDA approval for Cervarix is expected between October and January 2008, according to McClatchy/Raleigh News & Observer. GSK said that Cervarix is more effective than Gardasil and might prevent up to 80% of cervical cancers because of AS04, a booster ingredient in the vaccine. The company did not disclose what it plans to charge for Cervarix (McClatchy/Raleigh News & Observer, 3/30). GSK has applied for European approval of Cervarix and expects a decision in the coming months, Dow Jones/MarketWatch reports (Stovall, Dow Jones/MarketWatch, 3/29).