Merck has received an advice from the US Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee stating that the data presented supports an indication for Gardasil [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.
Merck Research Laboratories clinical research director Elizabeth Garner said that they were pleased with the outcome of the meeting and look forward to continued discussions with the FDA as it evaluates the data for the proposed indication.
The Committee's input will be considered by the FDA in its review of the supplemental biologics license application (sBLA) that Merck submitted for Gardasil in early 2010.
The efficacy of Gardasil against HPV-related anal disease was studied in a population of men who have sex with men because of the known high risk of anal infection and disease that occurs in this group.
Merck submitted the sBLA for use of Gardasil in both men and women because anal cancer affects both men and women and the disease is similar in both genders.
Gardasil is approved in the US for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts (condylomata acuminata) caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.