CervarixTreatment for Human Papillomavirus Prophylaxis
Update: Cervarix Now FDA Approved - October 16, 2009
GlaxoSmithKline Responds to FDA on Cervarix
GlaxoSmithKline Responds to FDA on Cervarix and Plans to Submit Final Study Data for Approval
LONDON and PHILADELPHIA, June 30, 2008 /PRNewswire-FirstCall/ -- GlaxoSmithKline today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of Cervarix, its vaccine to prevent cervical cancer.
GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007. In addition, given that final data from GSK's Phase III pivotal efficacy study, HPV-008, are expected to be available later this year, GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. GSK anticipates submitting these data in the first half of 2009. The timing depends on reaching a certain number of cases in order to conduct the final analysis. An FDA action on the application is expected to take up to six months following this submission. Interim data from this study were filed in the original application for the vaccine in March, 2007. The company does not expect that new clinical studies will be required for approval.
"Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for Cervarix," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "We continue to have positive and productive discussions with the FDA and remain confident in the vaccine's safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S."
To date, GSK's cervical cancer vaccine has been approved in 67 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 35 additional countries including Japan. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.
Burden of Cervical Cancer
Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.(1) In the United States, after breast cancer, cervical cancer is the second leading cause of cancer death in women ages 20 to 39.(2)
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 company information, please visit http://www.gsk.com/media.
GlaxoSmithKline Biologicals (GSK Biologicals) is a leading global vaccine manufacturer committed to preventing disease in people of all ages with innovative vaccines and delivery systems. The division, headquartered in Belgium, is active in vaccine research, development and production with more than 30 vaccines currently available globally and 20 more in development. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines -- an average of 3 million doses a day.
Cervarix is a registered trademark of the GlaxoSmithKline group of companies.
GSK cautionary statement regarding forward-looking statements
Under the safe harbour provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, 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 the Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2007.
1. World Health Organization. Initiative for Vaccine Research.
2. Jemal A, Murray T, Ward E, Sammuels A et al. Cancer Statistics, 2005. Cancer Journal for Clinicians 2005; 55; 10-30
CONTACT: UK Media enquiries: Philip Thomson, Alice Hunt, Gwenan White, orClaire Brough, +(020) 8047 5502; or US Media enquiries: Nancy Pekarek, LiadDiamond, Sarah Alspach, +1-215-751-7709, or Mary Anne Rhyne,+1-919-483-2839; or European Analyst-Investor enquiries: David Mawdsley,+(020) 8047 5564, Sally Ferguson, +(020) 8047 5543, or Gary Davies, +(020)8047 5503; or US Analyst-Investor enquiries: Frank Murdolo,+1-215-751-7002, or Tom Curry, +1-215-751-5419, all of GlaxoSmithKline
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Posted: June 2008
- FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine - October 16, 2009
- FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine - September 9, 2009
- Cervarix U.S. Regulatory Update - March 30, 2009
- GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervarix Cervical Cancer Vaccine - December 17, 2007
- GlaxoSmithKline Submits Biologics License Application to U.S. Food and Drug Administration for Cervarix - March 29, 2007