Merck & Co gets OK for Gardasil in anal cancer prevention in USA

The US Food and Drug Administration has approved US drugs giant Merck & Co’s (NYSE: MRK) cervical cancer vaccine Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] vaccine, Recombinant) for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18, and for the prevention of anal intraepithelial neoplasia (AIN), in both men and women aged nine to 26, the company reported last night.

The agency’s decision comes after an advisory committee recommendation for this indication last month (The Pharma Letter November 19). Gardasil is already Merck’s top-selling vaccine and generated sales of $316 million in the third quarter of this year, an increase of 2% on the like 2009 period, and $1.1 billion for the whole of last year.

Gardasil, which competes with UK-based GlaxoSmithKline’s Cervarix - is approved in the USA for use in girls and young women aged nine through 26 years for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts (condylomata acuminata) caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. Gardasil is also approved in the USA for use in boys and men ages nine through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11.