FDA Delays Approval Of Mercks HPV Vaccine Gardasil For Older Women

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Seniors / Aging
Article Date: 27 Jun 2008 - 5:00 PDT

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FDA has delayed a decision on Merck's application to expand marketing of its human papillomavirus vaccine Gardasil to women ages 27 to 45, the company said Wednesday, the Newark Star-Ledger reports (Newark Star-Ledger, 6/26). While Merck is expected to continue to pursue the age expansion, the company is not expected to pursue the expansion of HPV types covered by a new vaccine (Krauskopf, Reuters, 6/25).

In March, FDA granted priority review status to Merck's application meaning that the agency would decide on the application within six months. Gardasil currently is approved by FDA for use by girls and women ages nine to 26. The vaccine in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women's Health Policy Report, 3/21). The recent FDA letter does not affect Gardasil's current approval for girls and women ages nine to 26.

A Merck spokesperson said FDA has specific questions regarding Gardasil's effectiveness among older women. Merck said it has already discussed the questions with FDA and expects to respond to the agency in July. Amy Rose, a spokesperson for Merck, said, "Once we go back to the FDA, we'll have a better sense of what the review timing looks like." Linda Bannister, an analyst for Edward Jones, said, "It's hard to get a feel for if this is a dead issue or if this is delayed." She added, "At the minimum, it's going to be delayed" (Krauskopf, Reuters, 6/25). Steve Brozak, an analyst at WBB Securities, said, "This is clearly not what Merck wanted. It reflects the painstakingly slow process that the FDA has in approving anything." He added, "I think this is one [case] where [FDA] would rather err on the side of getting another 23 pounds of documents."

Beverly Lybrand, senior vice president and general manager of adolescent and adult vaccines at Merck, said, "We are committed to seeing Gardasil used to help prevent cervical cancer and other HPV diseases in the currently indicated population." She added, "We will continue to pursue this and other supplemental approvals to extend the use of this vaccine to others" (Newark Star-Ledger, 6/26).

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