FDA Grants Merck & Co. Priority Review for Cervical Cancer Vaccine
February 8, 2006
The Food and Drug Administration has granted Whitehouse Station, N.J.-based Merck & Co. priority review for the company's cervical cancer vaccine. An FDA decision on the vaccine, which would be sold under the brand name Gardasil, is expected by June 8. Gardasil is designed to protect against four strains of human papillomavirus that are linked to cervical cancer in women and to genital warts in men and women. If approved, Gardasil would be the first cervical cancer vaccine on the U.S. market. FDA grants priority review, which cuts about four months off the usual 10-month review period, for treatments it considers advancements over current therapies. Merck is also seeking approval in the European Union and in countries such as Brazil and Mexico.
Wall Street Journal
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