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FDA reviewers: Merck & Co.'s Gardasil effective against genital warts in males
  by Anna Bratulic September 04, 2009
In FDA documents released ahead of an advisory panel meeting, agency staff concluded that Merck & Co.'s Gardasil is effective at preventing genital warts caused by human papillomavirus strains 6 and 11 in males between 16 and 26 years old. A panel of experts is scheduled to meet September 9 to discuss whether to recommend approval of the product to prevent genital warts caused by these two HPV strains in males aged 9 to 26 years.
FDA reviewers noted that "in the limited safety database in males, no safety signals have been identified," and added that "the adequacy of the post-marketing plan to address safety in males in a broader population is being reviewed." In addition, agency staff noted that Merck had originally asked the FDA to approve Gardasil to prevent penile cancer, but explained that the company agreed to "evaluate a less broad indication focusing only on genital warts" because study data showed that the number of cases of precancerous growths was too small to evaluate.
As part of its filing to request expanded approval, Merck submitted data from a late-stage study released last year, which demonstrated that the vaccine prevented 90 percent of external genital lesions caused by HPV types 6, 11, 16 and 18 in adolescents and young men.
Merrill Lynch analyst David Risinger forecast that Gardasil sales could reach $2.7 billion in peak sales in 2011 if it is approved for males. Merck's HPV vaccine, which has already been authorised for use in males in some countries, is currently approved in the US for use in girls and women between the ages of 16 and 26 years.
Reference Articles
Merck Gardasil works against genital warts in males - (Bloomberg)
FDA: Merck's Gardasil vaccine effective in males - (CNN Money)
Vaccines and Related Biological Products Advisory Committee meeting Gardasil briefing document (pdf) - (FDA)
Merck's Gardasil seems OK for males - FDA memo - (Interactive Investor)
FDA: Merck's Gardasil stops genital warts in boys - (The Washington Post)
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