Further delays for GSK's Cervarix vaccine

UK drug major GlaxoSmithKline has submitted its reply to the US Food and Drug Administration's Complete Response Letter for its cervical cancer vaccine Cervarix that it received in December of last year.

Given that final data from GSK's Phase III efficacy study, HPV-008, are 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 US label. The firm expects to submit the data in the first half of 2009. An FDA action is expected to take up to six months following the submission. Interim data from the study were filed in the original application for the vaccine in March, 2007. The company does not anticipate that further clinical trials 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 US label for Cervarix," said Barbara Howe, vice president of North American vaccine development for GSK. "We continue to have positive and productive discussions with the FDA and remain confident in the vaccine..." she added.