GSK To Update FDA On HPV Vaccine Cervarix Later This Year, CEO Says

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Feb 2008 - 6:00 PST

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GlaxoSmithKline CEO Jean-Pierre Garnier on Thursday said that the company will provide FDA with updated information about its human papillomavirus vaccine Cervarix by the third quarter of 2008, Reuters reports. Garnier said that it is not possible to determine whether Cervarix -- which is available in Europe -- will become available on the U.S. market in 2008 but added that it is likely the agency will convene an advisory panel to consider the drug after a response is filed (Hirschler, Reuters, 2/7).

GSK in December 2007 announced that it had received a "complete response letter" from FDA for Cervarix. Such a letter is issued when FDA has completed the review of a product but still has questions. Some analysts said that the setback would delay approval for the vaccine by at least a few months and possibly more than one year. The company did not say which questions were raised in the letter or how long it would take to answer them.

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 (Daily Women's Health Policy Report, 12/18/07).

European Marketer of Gardasil Criticizes Cervarix

In related news, Didier Hoch -- president of Sanofi Pasteur, a joint company of Merck and Sanofi-Aventis that markets the HPV vaccine Gardasil in Europe -- said data from GSK about Cervarix are not conclusive, the Financial Times reports. Hoch added that the company's clinical study that directly compared the two vaccines is a "marketing gimmick." Hoch criticized the study comparing Gardasil and Cervarix for its small sample size, inclusion of people older than the vaccine's target population and use of an efficacy test that was not standardized. Claims that Cervarix would provide protection against a number of HPV strains remained speculative, Hoch added. According to the Financial Times, Hoch's criticism is in part an attempt to "shore up" sales of Gardasil, which has already been approved and distributed in the U.S. and Europe (Jack, Financial Times, 2/7).

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