Regulatory Update - GSK receives positive CHMP opinion for Cervarix™ two-dose schedule

GSK Press Release:

Regulatory Update - GSK receives positive CHMP opinion for Cervarix™ two-dose schedule

Today, GlaxoSmithKline plc (GSK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending marketing authorisation for a two-dose schedule in 9-14 year old girls for its cervical cancer vaccine, Cervarix™ [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant].

“We are delighted by the positive opinion issued by CHMP on a two-dose schedule for Cervarix. It represents another major milestone in our commitment to reducing the global burden of cervical cancer which remains high. Many countries are unable to implement national immunisation programmes in young adults with high coverage. A two-dose vaccine schedule has the potential to be easier to deliver than a three-dose schedule, thereby expanding the population that could benefit from protection.” said Thomas Breuer, Senior Vice President and Lead Physician, GSK Vaccines.

The EU licence application is based on the results of a Phase III study (HPV-070) which showed that two doses of the vaccine in girls aged nine to fourteen years provide an immunogenicity matching the currently licensed three-dose schedule in fifteen to twenty five year olds.

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation.

The vaccine is currently approved in the EU for use in females from the age of 9 years, administered according to a three-dose schedule (vaccination at months 0,1 and 6) for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types. The two-dose schedule will only apply to vaccination of girls aged 9-14. The three-dose schedule remains recommended for girls and women aged 15 years and above.

Cervarix™ is also approved in the US. For the full US Prescribing Information and EU Patient Information Leaflet, which includes information on the approved use of Cervarix, please visit http://www.gsk.com/products.html.

GlaxoSmithKline Vaccines - is active in vaccine research and development. Headquartered in Belgium, GSK Vaccines has 13 manufacturing sites strategically positioned around the globe. Of the 883 million doses of our vaccines we distributed in 2012, over 80% went to developing countries, which include the least developed, low- and middle-income countries.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.