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New FDA approval for Merck's Gardasil

Merck's HPV vaccine, Gardasil, has received approval from the US Food and Drug Administration for the prevention of anal cancer due to HPV

Merck's human papillomavirus (HPV) vaccine Gardasil has received approval from the US Food and Drug Administration (FDA) for the prevention of anal cancer due to HPV types 6, 11, 16, and 18 in individuals aged nine to 26.

The approval was made following a trial which found Gardasil to be 78 per cent effective in the prevention of precancerous lesions, known as anal intraepithelial neoplasia (AIN), caused by anal HPV-16/18 infection.

The vaccine is already approved for females aged nine to 26 for the prevention of cervical, vulvar, and vaginal cancer caused by HPV. The FDA had also previously stated Gardasil can be used for the prevention of genital warts caused by HPV types 6 and 11 in both males and females.

"We are pleased that with this new indication for Gardasil against HPV-related anal cancer and disease, both males and females can be protected against cancer, which further reinforces the importance of vaccinating both genders," said Dr Richard M Haupt, executive director, Merck Research Laboratories.

Dr Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, also commented on the approval: "Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure."

A panel of FDA advisors had previously recommended the agency approve Gardasil for the indication of preventing anal cancer.

According to the FDA, anal cancer incidence in the general population is increasing with HPV associated with around 90 per cent of disease cases. It is estimated there are around 5,300 people diagnosed with anal cancer each year in the US, with 60 per cent of those diagnosed women.

23rd December 2010

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