Glaxo’s cervical cancer vaccine faces US battle

The Associated Press

May 08, 2009 08:36 AM

New studies show GlaxoSmithKline PLC’s vaccine Cervarix blocks the virus that causes cervical cancer, but if it wins approval for U.S. sales, it will face an uphill battle against Gardasil, which has owned the market here for three years.

Cervarix, Glaxo’s vaccine against human papilloma virus or HPV, already is approved in more than 90 other countries, but has been held up by delays in the United States. Several years ago, the British drugmaker was in a neck-and-neck race with rival Merck & Co., Gardasil’s maker, to be first on the U.S. market, but it lost when Gardasil got approved in June 2006.

Late in 2007, U.S. regulators said they wouldn’t approve Cervarix without additional data. from a large study still in progress at the time.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.