Published on Friday, October 29, 2010
FDA’s Center for Biologics Evaluation and Research (CBER) also concluded that it is reasonable to extrapolate efficacy data in males to support the indication in females. Merck submitted a single Phase III trial conducted only in males as part of the application.
Gardasil is approved in the U.S. for use in males and females ages 9-26 to prevent genital warts caused by HPV types 6 and 11. The vaccine is also approved for use in females ages 9-26 to prevent cervical, vulvar and vaginal cancers caused by HPV types 16 and 18, and to prevent precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.