GSK Submits Final Data For Application To Market HPV Vaccine Cervarix In U.S.

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 01 Apr 2009 - 6:00 PDT

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GlaxoSmithKline on Monday said it has submitted final data to FDA in support of its application to market the human papillomavirus vaccine Cervarix in the U.S., the AP/Forbes.com reports (AP/Forbes.com, 3/30). Cervarix is approved for use in more than 90 countries and protects against HPV types 16 and 18, which cause about 70% of cervical cancers (GSK release, 3/30). Gardasil, a rival HPV vaccine manufactured by Merck, already is approved in the U.S.

FDA has reviewed interim data from the new study and will issue a decision after analyzing the final results, the AP/Forbes.com reports. Barbara Howe, vice president and director of GSK's North American Vaccine Development unit said, "The data submitted to the FDA reaffirm our confidence in the vaccine's safety and efficacy (AP/Forbes.com, 3/30).

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