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FDA Advisory Committee Supports Approval of Gardasil for Prevention of Anal Cancer and AIN in Both Men and Women

November 17, 2010

Merck announced on November 17 that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that data presented support an indication for Gardasil, the vaccine that prevents certain types (Types 6, 11, 16, and 18) of the Human Papillomavirus (HPV) for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females between the ages of 9 and 26. The Committee's input will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for Gardasil in early 2010. The FDA is not bound by the Committee's guidance, but takes its advice into consideration when reviewing vaccines.

"We are pleased with the outcome of today's meeting and look forward to continued discussions with the FDA as it evaluates the data for the proposed indication," said Elizabeth Garner, MD, MPH, director, clinical research, Merck Research Laboratories. "Today's discussion brings us closer to being able to also provide Gardasil to men and women for the prevention of anal cancer and AIN."

The efficacy of Gardasil against HPV-related anal disease was studied in a population of men who have sex with men because of the known high risk of anal infection and disease that occurs in this group. Merck submitted the sBLA for use of Gardasil in both men and women because anal cancer affects both men and women and the disease is similar in both genders. Up to 90 percent of anal cancers are caused by HPV, with HPV 16 and 18 causing approximately 80 percent of those cases.

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