GSK: Key Cervarix study to be completed this year

GlaxoSmithKline (GSK) has confirmed that a vital phase III study for its cervical cancer vaccine Cervarix will be completed during 2008.

It said the final results of the HPV-008 study would be used to add to its application for approval of the vaccine to the US Food and Drug Administration.

The company forecast the submission of this data in the first half of 2009, subject to the conducting of a final analysis.

GSK said it does not anticipate the need for any further clinical studies for the compound to be approved.

Every year, 500,000 women are diagnosed with cervical cancer, with 280,00 dying from the disease.

Cervarix is currently approved in 67 countries worldwide, including the 27 EU member states, Mexico and Australia.

Barbara Howe, vice-president and director of North American vaccine development at GSK, said; “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.”

She added GSK remains confident in the safety and efficacy of the drug and is continuing to have positive discussions with the regulatory authorities in the US.

Last month, GSK announced that Cervarix won the tender for the UK national immunisation programme.