|
FDA action on the application is expected to take as long as 6 months following the additional data submission, meaning a potential Cervarix debut in late 2009.5 Company representatives do not expect new clinical studies will be required for approval.
To date, 67 countries around the world have approved Cervarix, including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. GSK has submitted licensing applications in more than 35 additional countries, including Japan. GSK also submitted the vaccine to the World Health Organization for prequalification in September 2007.5
Kerri Penno (kpenno@advanceweb.com) is senior associate editor of ADVANCE.
References
1. FDA approves Merck's GARDASIL to protect against two additional cancers vaccine now indicated for prevention of vaginal and vulvar cancers in girls and women ages 9 through 26. Available at: ww.merck.com/newsroom/press_releases/product/2008_0925.html. Last accessed Nov. 5, 2008.
2. FDA. FDA approves expanded uses for Gardasil to include preventing certain vulvar and vaginal cancers. Available at: www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html. Last accessed Nov. 5, 2008.
3. FDA. GARDASIL questions and answers. Available at: www.fda.gov/CBER/products/hpvmer060806qa.htm. Last accessed Nov. 5, 2008.
4. Merck. Merck comments on New England Journal of Medicine article by J. Kim and S. Goldie. Available at: www.merck.com/newsroom/press_releases/product/2008_0820.html. Last accessed Nov. 3, 2008.
5. GlaxoSmithKline. GlaxoSmithKline responds to FDA on Cervarix and plans to submit final study data for approval. Available at: www.gsk.com/media/pressreleases/2008/2008_pressrelease_10073.htm. Last accessed Nov. 5, 2008.
|