FDA Approves Merck’s HPV Vaccine for Anal Cancer and AIN Prevention

23 December 2010 (Last Updated December 23rd, 2010 18:30)

The US Food and Drug Administration (FDA) has approved a new indication for Merck's Gardasil human papillomavirus (HPV) vaccine. The approval applies to the prevention of anal cancer caused by HPV types 16 and 18, and the prevention of anal intraepithelial neoplasia (AIN) caused by HPV

The US Food and Drug Administration (FDA) has approved a new indication for Merck's Gardasil human papillomavirus (HPV) vaccine.

The approval applies to the prevention of anal cancer caused by HPV types 16 and 18, and the prevention of anal intraepithelial neoplasia (AIN) caused by HPV types 6, 11, 16 and 18 in males and females aged 9-26 years old.

Gardasil has approved in the US for use in girls and young women aged 9-26 to prevent cervical, vulvar and vaginal cancers caused by HPV types 16 and 18, genital warts caused by HPV types 6 and 11, and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

In addition, Gardasil was approved in the US for use in boys and men aged 9-26 for the prevention of genital warts caused by HPV types 6 and 11.

Merck Research Laboratories executive director Richard M Haupt said that the company was pleased with the new indication for Gardasil.