US FDA says no to Gardasil for older women

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FDA Rejects Gardasil for Older Women

By John Gever, Senior Editor, MedPage Today
Published: April 07, 2011

The FDA has declined to expand the approved age range for the human papillomavirus (HPV) vaccine Gardasil to 45, according to the product's manufacturer.

In the agency's judgment, clinical trial data failed to show that Gardasil effectively prevented infections in women 27 to 45 years old, Merck said in a press release.

On the basis of the data Merck submitted, the vaccine's label will now state that the product "has not been demonstrated to prevent HPV-related cervical intraepithelial neoplasia 2/3 or worse in women older than 26 years of age," according to the company.

The decision was based on a trial in 3,253 women ages 27 to 45. Although the vaccine appeared to prevent persistent HPV infection, no significant benefit was found for more important outcomes such as high-grade neoplastic lesions or cervical cancer when all participants were included irrespective of baseline HPV status.

A summary of these data is now included in Gardasil's prescribing information.

The quadrivalent vaccine covers HPV subtypes 6, 11, 16, and 18 and is currently approved for females and males 9 to 26 years old to prevent various conditions associated with the virus, including cervical cancer, anal cancer, and genital warts.

To read the story online go to MedPage Today (to access the site you will be asked to register, although it is free)