FDA approves genital warts vaccine in males

ROCKVILLE, Md. The Food and Drug Administration has approved a genital warts vaccine for use in males.

The FDA announced the approval of Merck & Co.’s Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for the prevention of HPV infection in boys and men ages 9 to 26 years. HPV infects 2-in-1,000 men in the United States each year. It also is a leading cause of cervical cancer in women.

“This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26 and, as a result, fewer men will need to undergo treatment for genital warts,” FDA Center for Biologics Evaluation and Research acting director Karen Midthun said in a statement.

The FDA approved a competitor drug, GlaxoSmithKline’s Cervarix (HPV bivalent [types 16 and 18] vaccine, recombinant), for use in girls and women last week.