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US approval for Cervarix delayed

GSK has published an update regarding its application to the FDA for US approval of its cervical cancer drug, Cervarix

GlaxoSmithKline (GSK) has published an update regarding its application to the Food and Drug Administration (FDA) for US approval of its cervical cancer drug, Cervarix.

The company has responded to the FDA's complete response letter answering additional questions raised in December 2007. Final results from GSK's phase III study, HPV-008, are expected to be available later this year; to ensure they are included in the US label, GSK has decided to delay its approval application so that it includes these data.

Depending on a certain number of cases for analysis being reached, GSK anticipates submitting final data in the first half of 2009. It is anticipated that the FDA will require six months from submission to make an action.

"Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the US label for Cervarix," said Dr Barbara Howe, vice president and director, North American Vaccine Development, GlaxoSmithKline. "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 US."

Cervarix is currently approved as a cervical cancer vaccine in 67 countries. The UK Department of Health recently awarded GSK with a contract to supply Cervarix for a national human papillomavirus (HPV) vaccination programme.

Data from the World Health Organisation (WHO) shows that more than 500,000 women worldwide are newly diagnosed with cervical cancer, and over 280,000 women die from the disease each year.

1st July 2008


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