Drug Maker Merck Seeks Gardasil Approval for Boys

On Tuesday, Merck & Co. announced that in late December it submitted an application to the Food and Drug Administration seeking approval of its human papillomavirus virus (HPV) vaccine for use in boys. Gardasil prevents infection with the sexually transmitted virus and thus cancers of the genital organs, Merck said.

In June 2006, FDA approved use of Gardasil in females ages nine to 26 to prevent cervical cancer. Last June, that approval was expanded to include women ages 27 to 45. Gardasil is one of the most expensive vaccines on the market, costing roughly $360 for the three-shot series.

In its December application, Merck included research data from a study of around 4,000 males ages 16 to 26. That study showed Gardasil was 90 percent effective in preventing penile cancer and genital warts caused by four HPV strains. FDA has two months to decide whether the application for use in males meets its standards. Reviews can then take 10 months or longer.

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