Regulatory update – GSK announces EU submission for Cervarix® two dose schedule
London UK - GlaxoSmithKline (GSK) plc today announced the submission of a regulatory application in the European Union for a two dosing schedule in 9-14 year old girls for its cervical cancer vaccine, Cervarix ® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant].
A Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMA)for the vaccine to allow for administration according to a two-dose schedule (0,6 months) in girls aged 9-14 years old for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.
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 in 9-14 year old girls is intended to be an alternative dosing schedule and not intended to replace the three-dose schedule’
The use of Cervarix in a two dose schedule (vaccination at months 0 and 6) in girls aged 9-14 years old is investigational and not approved anywhere in the world.
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
About GSK Vaccines
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.
GlaxoSmithKline – 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
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under Item 3.D ’Risk factors’ in the company’s Annual Report on Form 20-F for 2012.
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