GSK Does Not Expect FDA Approval Of HPV Vaccine Cervarix Until End Of 2009

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 03 Jul 2008 - 6:00 PST

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GlaxoSmithKline on Monday said it does not expect to receive FDA approval for its human papillomavirus vaccine Cervarix until late 2009, Reuters reports. GSK said it has decided to wait until results from a Phase III trial of the vaccine are available before seeking U.S. approval. The study results likely will be submitted to FDA in the first half of 2009, with an FDA decision expected no more than six months later. GSK is competing with Merck for HPV vaccination contracts around the world (Hirschler, Reuters, 6/30).

Cervarix and Merck's FDA-approved vaccine Gardasil in clinical trials 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 (Daily Women's Health Policy Report, 6/20). Both vaccines are designed to be given to girls and young women but have different properties (Reuters, 6/30). According to Reuters, Cervarix uses a "novel adjuvant," or additive, that GSK says makes it longer lasting. Cervarix has been approved in 67 countries, including Australia, European Union countries and Mexico (Debreczeni, Dow Jones, 6/30).

FDA in December 2007 requested additional information about the vaccine before issuing a decision on GSK's application for Cervarix (Deighton, Thomson Financial/Forbes, 6/30). GSK CEO Jean-Pierre Garnier in February said that the company will provide FDA with the requested information by the third quarter of 2008 (Daily Women's Health Policy Report, 4/11). The company said it decided to wait until the results from the Phase III trial are available because it expects the trial to find a longer duration of safety and efficacy, according to Thomson Financial/Forbes (Thompson Financial/Forbes, 6/30).

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