GSK cancer vaccine Cervarix faces further delays

Source: Healthcare Digital

Date :01/07/2008 09:15:30

GlaxoSmithKline plc said on Monday, June 30, that it does not expect to win US approval for the company's experimental cervical cancer vaccine Cervarix until late 2009.

In a response to questions raised by the US Food and Drug Administration (FDA) in December, the London-based drugmaker said it will now await final results from its phase-three study HPV-008 in order to "augment its application for approval with these data to ensure they are included in the US label".

Interim results from the study were filed in the original application for Cervarix in March 2007. GSK added it did not expect the FDA to require new clinical studies for approval.

Cervical cancer vaccine

Barbara Howe, vice-president and director of GSK's North American Vaccine Development, said the company remains confident in the vaccine's efficacy and continues to have positive discussions with the FDA.

"We look forward to bringing this important new cervical cancer vaccine to girls and women in the US," she said.

Last week, Cervarix was chosen as the vaccine to be used in The Department of Health’s upcoming national cervical cancer immunisation programme.