Merck Seeks FDA Approval For HPV Vaccine Use In Boys, Young Men

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Men's health;  Pediatrics / Children's Health;  Regulatory Affairs / Drug Approvals
Article Date: 07 Jan 2009 - 1:00 PDT

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Merck is seeking FDA approval for the use of its human papillomavirus vaccine, Gardasil, for boys and young men ages nine to 26, the Wall Street Journal reports. Merck is seeking the approval for the prevention of male genital warts and other lesions, for which Gardasil was shown effective in recent studies, according to a Merck spokesperson. The Journal reports that the approval would have the potential to "greatly expan[d] the market for the drug," which currently is approved for use in girls and young women and has been a "key product" for Merck. Worldwide sales estimates of Gardasil in 2008 were as high as $1.6 billion, although sales recently have decreased (Rockoff, Wall Street Journal, 1/6). According to CNBC.com, Gardasil was approved in 2006 for girls and young women to prevent certain strains of HPV, which is the leading cause of cervical cancer and a sexually transmitted virus that men carry. Merck also has applied for FDA approval for older women to use Gardasil (Huckman, CNBC.com, 1/5).

Wall Street Journal's Health Blog also included an entry on the approval application (Rockoff, Health Blog, WSJ.com, 1/5).

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