GlaxoSmithKline has responded to questions raised in an FDA "Complete Response" Letter regarding its cervical cancer vaccine Cervarix and will submit additional efficacy data in the first half of 2009, the firm announced June 30.

The additional data will be the final results from the Phase III pivotal efficacy study, HPV-008. GSK expects FDA action on the application to take up to six months from the submission of the data.

GSK said it is submitting the final data to ensure its inclusion in the U.S. label. Interim data from the study were filed in the original application, which the firm submitted in March 2007 (¹ Also see "GlaxoSmithKline Submits Cervarix BLA" - Pink Sheet, 29 March, 2007.).

The firm expects the study data to be available later this year, but said its submission to the agency will depend on when enough cases have been recorded to conduct the final analysis. As a result, the timeframe for final FDA action and launch of the vaccine remains unclear.

GSK received the complete response letter in December 2007, but would not reveal what issues were raised by the agency (² Also see "GSK Receives “Complete Response” Letter For Cervarix BLA" - Pink Sheet, 17 December, 2007.).

The delay caused by the letter put Cervarix even further behind Merck's Gardasil , which has been approved to prevent cervical cancer and other diseases caused by human papillomavirus since 2006 and already has reached blockbuster status.

GSK does not expect that new clinical studies will be required for approval, but then-CEO J.P. Garnier said in February that the firm expects the vaccine will require review by an FDA advisory committee (³ Also see "GSK Will Answer FDA “Complete Response” Letter For Cervarix In Second Quarter" - Pink Sheet, 7 February, 2008.).

Cervarix has been approved in 67 countries, including those in the European Union.

-Jamie Hammon (j.hammon@elsevier.com)

GSK’s Responds To FDA On Cervarix, Will Augment BLA With More Efficacy Data

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