GSK Cervarix® two-dose schedule receives European marketing authorisation
20 December 2013
Issued: Friday 20 December 2013, London UK
GlaxoSmithKline (GSK) announced today that the European Commission has granted marketing authorisation for its cervical cancer vaccine Cervarix® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] as a two-dose schedule for girls aged 9 to 14. This is the first time a cervical cancer vaccine has been approved as a reduced dosing schedule and signifies potential for greater vaccination coverage rates and improved cervical cancer protection worldwide.
Thomas Breuer, Senior Vice-President and Lead Physician, GSK Vaccines, said “We’re delighted to receive approval for Cervarix as a 2-dose schedule. This new dosing schedule can make vaccination easier to implement and more affordable, which in turn creates the potential for higher vaccination coverage and more girls being protected against cervical cancer.”
Worldwide, cervical cancer claims an average of one life every two minutes with an estimated 275,000 deaths from the disease each year.1 Virtually all cases of cervical cancer are caused by a virus called human papillomavirus (HPV).2 There are more than 100 known types of HPV, 3 of which at least fifteen can cause cervical cancer.4 HPV 16 and 18 are the most common cancer-causing virus types and account for approximately 70% of all cervical cancer cases globally.5 Up to 80% of women worldwide will acquire an HPV infection in their lifetime and almost 40% of these infections will be with a cancer-causing virus type.2,6,7
The EU approval of Cervarix as a 2-dose schedule is based on the results of two clinical studies HPV 048 and HPV 070 which assessed both the immunogenicity and the safety of two doses of Cervarix.8,9 The findings from these two studies were consistent and demonstrated that two doses of Cervarix in 9 to 14 year old girls is comparable to three doses in 15 to 25 year old girls and women.8,9 This data looked not only at vaccine types 16 and 18 but also at non-vaccine types 31 and 45. In study HPV-048, these results were sustained for a total of four years.8,9
The vaccine is already 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 (0, 6 months) will apply to vaccination of girls aged 9-14. The three-dose schedule remains in the label for girls and women aged 15 years and above.
Outside of the EU, Cervarix two-dose schedule in girls aged 9-14 years is already approved in twelve countries (including Panama, Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria, Ghana, Pakistan and Bangladesh).
Cervarixis 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 GSK.com.
Cervarix is a registered trademark of the GlaxoSmithKline group of companies.
- Cervarix™ is a vaccine that helps protect girls and women against premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer10
- In clinical trials, the most common adverse events after vaccination with Cervarix™ were injection site reactions (such as pain, redness, swelling), headache, muscle pain and fatigue10
- Since its launch in 2007, Cervarix™ has become available in 130 high, middle and low income countries around the world11
- To date, over 41 million doses of Cervarix™ have been distributed12
- The vaccine is manufactured at GSK Biologicals in Wavre, Belgium
- The Summary of Product Characteristics for Cervarix™
About GSK Vaccines
GlaxoSmithKline Vaccines is active in vaccine research and development. Headquartered inBelgium, 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.
For more information:
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.
1. GLOBOCAN 2008. Cervical Cancer Incidence and Mortality Worldwide in 2008 Summary. [Last accessed: December 2013]
2. Bosch FX, de Sanjose S. Chapter 1: Human papillomavirus and cervical cancer – burden and assessment of causality. Journal of the National Cancer Institute Monographs. 2003; 3-13
3. World Health Organization. Expert Committee on Biological Standardization. Guidelines to assure the quality, safety and efficacy of recombinant Human Papillomavirus virus-like particle vaccines. [Last accessed: December 2013]
4. Muñoz N, Bosch FX, de Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003; 348: 518-527
5. De Sanjose S et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. The Lancet Oncology. 2010. 11:1048-1056
6. Brown DR, Shew ML, Qadadri B et al. A longitudinal study of genital human papillomavirus infection in a cohort of closely followed adolescent women. Journal of Infectious Diseases. 2005; 191: 182-192
7. Gravitt PE, Jamshidi R. Diagnosis and management of oncogenic cervical human papillomavirus infection. Infectious Disease Clinics of North America. 2005;19:439-458
8. Puthanakit T, Schwartz T, Esposito S. Immune responses to a 2-dose schedule of the hpv-16/18 as04-adjuvanted vaccine in girls (9-14) versus 3 doses in women (15-25): a randomised trial. EUROGIN 2013. [Last accessed: December 2013]
9. Romanowski B, Schwartz T, Ferguson L. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination. EUROGIN 2013. [Last accessed: December 2013]
10. Summary of Product Characteristics. Cervarix™. GlaxoSmithKline. [Last accessed: December 2013]
11. GSK Data on file 2013
12. GSK Data on file 2013
This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.