GARDASIL for Males?
Earlier today, Merck & Co. Inc announced the FDA's Vaccines and Related Biological Products Advisory Committee recommended approving GARDASIL for males.
The committee agreed efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL in boys and men ages 9 through 26 for preventing genital warts caused by human papillomavirus (HPV) types 6 and 11.
The FDA will consider the committee's recommendation before presenting a ruling on Merk's supplemental Biologics License Application, expected later this year.
Initially approved in June 2006, GARDASIL is currently indicated for use in girls and young women ages 9 through 26 for preventing cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. More than 50 million doses have been distributed worldwide through June 2009.