FDA Committee Supports Merck’s Gardasil For Anal Cancer Prevention

StockMarketsReview.com

November 17, 2010

(RTTNews) – Drug maker Merck & Co. Inc. (MRK) said Wednesday that an U.S. Food and Drug Administration Advisory Commitee supported an approval for its human papillomavirus vaccine ‘Gardasil’, for prevention of anal cancer and anal intraepithelial neoplasia in both males and females aged 9 to 26 years.

Merck said the input from FDA’s Vaccines and Related Biological Products Advisory Committee will be considered by the FDA in its review of the supplemental Biologics License Application submitted for Gardasil in early 2010. The FDA, however, is not bound by the Committee’s guidance.

The Advisory Committee’s approval pertains to Gardasil, Human Papillomavirus Quadrivalent Types 6, 11, 16, and 18.

Gardasil, also known as Silgard, is a vaccine proven to prevent certain types of human papillomavirus or HPV.

Currently, Gardasil is approved in the U.S. for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers, genital warts, and and precancerous or dysplastic lesions caused by certain types of HPV.

The vaccine is also approved in the U.S. for boys and men ages 9 through 26 years for the prevention of genital warts caused by certain types of HPV.

In its third quarter, Merck reported Gardasil sales that edged up 2% $316 million.

Elaborating on the FDA Advisory Committee’s support for Gardasil, Merck said the efficacy of the vaccine against HPV-related anal disease was studied in a group of homosexual men, susceptible to high risk of anal infection and other disease.

Merck said it submitted the sBLA for use of Gardasil in “both men and women” since anal cancer affects both genders. According to the company, up to 90% of anal cancers are caused by HPV, with HPV 16 and 18 casuing 80% of them.

Presently, Gardasil is approved in 121 countries, and additional applications are under review with regulatory agencies in many more countries around the world.

MRK is trading at $34.59, up $0.49 or 1.44%, on the NYSE.

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