FDA To Review Merck's Application To Expand HPV Vaccine Gardasil's Approval To Older Women

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology
Article Date: 24 Mar 2008 - 5:00 PDT

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FDA has granted priority review status to Merck's application to expand marketing of its human papillomavirus vaccine Gardasil to women ages 27 to 45, the company said Wednesday, Reuters reports. The designation means that an FDA decision could come within six months, according to Reuters. currently is approved by the FDA for use by girls and women ages nine to 26 (Reuters, 3/19).

Gardasil 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, 2/7). FDA is expected to make a decision on the application within six months, rather than the typical 10 months, according to Reuters (Reuters, 3/19).

In the application, Merck noted that women are at risk of HPV throughout their lives. Merck spokesperson Kelley Dougherty said that because researchers have found few women are infected with all four HPV types that the vaccine protects against, Gardasil would prevent women infected with one or more of the strains from contracting the others. She added that there are no commercial tests currently available to differentiate among the strains of HPV (AP/San Diego Union-Tribune, 3/19).

Seamus Fernandez, an analyst at Leerink Swann, said the priority review status is a positive surprise. He added that he anticipates a "straightforward" review of the application because of the lack of serious side effects among women who received the vaccine in clinical trials (Reuters, 3/19).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

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