FDA Approves Gardasil to Prevent Genital Warts in Males
Agency Also Approves Bivalent HPV Vaccine for Girls, Young Women
By News Staff
The FDA has expanded its approval of Merck & Co. Inc.'s quadrivalent human papillomavirus, or HPV, vaccine, which is marketed as Gardasil, to include use of the vaccine to prevent genital warts in boys and men ages 9-26 years. The agency also has given a thumbs-up to a bivalent HPV vaccine for girls and young women.
In an Oct. 16 news release, the FDA said that during clinical trials in more than 4,000 males, Gardasil was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11.
Gardasil was approved in 2006 for use in girls and young women ages 9-26 years for the prevention of cervical cancer, vulvar cancer, vaginal cancer and precancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18.
Merck said in an Oct. 16 news release that HPV types 16 and 18 account for 70 percent of cervical and vaginal cancers and as much as 50 percent of vulvar cancers. Types 6 and 11 cause about 90 percent of all genital warts, according to the vaccine manufacturer.
FDA approval is just the first step in the expansion of the use of Gardasil. The CDC's Advisory Committee on Immunization Practices, or ACIP, is scheduled to vote (3-page PDF; About PDFs) on whether to recommend use of the vaccine in males when it meets Oct. 21 in Atlanta.
Merck, however, already has announced that the company plans to extend its patient assistance program to cover 19- to 26-year-old uninsured males who receive Gardasil, starting Nov. 1. The manufacturer also plans to extend its rebate and dose replacement programs for the vaccine.
Meanwhile, Merck's vaccine soon will have competition from GlaxoSmithKline Biologicals, or GSK. The FDA approved GSK's bivalent HPV vaccine, Cervarix, on Oct. 16 for the prevention of cervical cancer and precancerous lesions caused by HPV types 16 and 18 in girls and women ages 10-25.
Like Gardasil, Cervarix is administered in a three-dose series.
Gardasil was approved in 2006 for use in girls and young women ages 9-26 years for the prevention of cervical cancer, vulvar cancer, vaginal cancer and precancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18.
Merck said in an Oct. 16 news release that HPV types 16 and 18 account for 70 percent of cervical and vaginal cancers and as much as 50 percent of vulvar cancers. Types 6 and 11 cause about 90 percent of all genital warts, according to the vaccine manufacturer.
FDA approval is just the first step in the expansion of the use of Gardasil. The CDC's Advisory Committee on Immunization Practices, or ACIP, is scheduled to vote (3-page PDF; About PDFs) on whether to recommend use of the vaccine in males when it meets Oct. 21 in Atlanta.
Merck, however, already has announced that the company plans to extend its patient assistance program to cover 19- to 26-year-old uninsured males who receive Gardasil, starting Nov. 1. The manufacturer also plans to extend its rebate and dose replacement programs for the vaccine.
Meanwhile, Merck's vaccine soon will have competition from GlaxoSmithKline Biologicals, or GSK. The FDA approved GSK's bivalent HPV vaccine, Cervarix, on Oct. 16 for the prevention of cervical cancer and precancerous lesions caused by HPV types 16 and 18 in girls and women ages 10-25.
Like Gardasil, Cervarix is administered in a three-dose series.
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