GlaxoSmithKline has submitted its response to questions raised by the FDA regarding its application for approval of Cervarix, its vaccine to prevent cervical cancer.
GSK will also submit Phase III efficacy study data from HPV-008, which is expected to be available later this year. GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. The company anticipates submitting these data in the first half of 2009 and FDA action is expected within six months following this submission. Interim data from this study were filed in the original application for the vaccine in March 2007. The company does not expect that new clinical studies will be required for approval.
"Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for Cervarix," said Barbara Howe, M.D., vice president and director, North American Vaccine Development, GSK. "We continue to have positive and productive discussions with the FDA and remain confident in the vaccine's safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S."
The vaccine is currently approved in 67 countries including the EU, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 35 additional countries including Japan.
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