FDA Denies Approval Of Gardasil For Use In Older Women

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology;  Seniors / Aging;  Regulatory Affairs / Drug Approvals
Article Date: 13 Jan 2009 - 3:00 PST

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FDA on Friday denied approval of Merck's application for use of the human papillomavirus vaccine Gardasil in women ages 27 to 45, Dow Jones/MarketWatch reports. The vaccine currently is approved for the prevention of genital warts and cervical, vulvar and vaginal cancers. The vaccine is approved for use in women ages nine to 26. Gardasil protects against four strains of HPV that cause the majority of cervical cancer and genital warts cases. According to Dow Jones/MarketWatch, this latest delay "further clouds the outlook for Gardasil, whose sales growth hit a wall last year after brisk growth following its introduction in 2006."

FDA said it wants to wait until the completion of an ongoing, four-year trial of the vaccine before it will consider approval for older women. Merck said the data likely would be available by the end of the year, which means approval would be unlikely before 2010. Peter Kim, research chief at Merck, said the company is "committed to continuing to pursue the use of Gardsil in this important group of women -- many of whom remain at risk for HPV-related disease throughout their lifetimes."

Dow Jones/MarketWatch reports that the rejection marks the second delay in efforts by Merck to gain approval for the use of Gardasil in older women. FDA in June 2008 said that there were issues with Merck's application that would prevent approval from occurring within the expected review period. Dow Jones/MarketWatch reports that one possible issue is that Gardasil is most effective in younger women who have not yet been exposed to HPV. Tim Anderson, a Sanford Bernstein analyst, said that the efficacy of Gardasil "drops sharply" after women have been exposed to HPV and that "this is probably the genesis of the problem with the older female population that [Merck] has been pushing for in this new application." He added, "While the vaccine's efficacy is markedly lower in sexually experienced females, it is still better than nothing, but this does not have the effect of tilting the usual risk-benefit calculation."

According to Merck, the delay will not affect its recent application for approval of Gardasil use in men ages nine to 26 for prevention of external lesions caused by HPV strains. Action on that application could come later this year, according to Dow Jones/MarketWatch (Loftus, Dow Jones/MarketWatch, 1/9).

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