Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support 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.

"We are pleased with the outcome of today's meeting and look forward to continued discussions with the FDA as it evaluates the data for the proposed indication," said Elizabeth Garner, M.D., MPH, director, clinical research, Merck Research Laboratories. "Today's discussion brings us closer to being able to also provide GARDASIL to men and women for the prevention of anal cancer and AIN."

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 FDA is not bound by the Committee's guidance, but takes its advice into consideration when reviewing vaccines.

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. Up to 90 percent of anal cancers are caused by HPV, with HPV 16 and 18 causing approximately 80 percent of those cases.

GARDASIL is approved in the U.S. 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. HPV types 16 and 18 account for approximately 75 percent of cervical cancer cases, and HPV types 6 and 11 account for approximately 90 percent of genital warts cases. GARDASIL is also approved in the U.S. for use in boys and men ages 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11.