FDA advisory committee recommends expanded use of Gardasil

WHITEHOUSE STATION, N.J. — A Food and Drug Administration advisory committee has recommended expanded approval of a vaccine for genital warts.

Merck announced Wednesday that the FDA Vaccines and Related Biological Products Advisory Committee recommended approval of Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for males and females ages 9 to 26 years to prevent anal cancer and anal intraepithelial neoplasia, both diseases that result from infection by the human papillomavirus.

Merck’s application was based on a clinical study of Gardasil in men who have sex with men, for whom anal infection by HPV is a high risk, though it submitted its application for men and women because the disease affects and is similar in both genders.


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