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.
Final results from that 18,000-woman study and two others are being presented this weekend at a conference in Sweden on papillomavirus. The data was submitted to the Food and Drug Administration on March 30, and FDA is expected to decide whether to approve Cervarix within several months.
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