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FDA Panel Backs New Use for Gardasil Vaccine

By Pharmaceutical Processing | November 18, 2010

WASHINGTON (AP) — A federal health panel says evidence supports expanding use
of Merck’s Gardasil vaccine to prevent anal cancer in
young men and women.

The panel of Food and Drug Administration advisers said a 4,000-patient study
conducted by Merck & Co. Inc. shows the vaccine lowers the risk of anal
cancer in men. They said these results can also be applied to women.

Anal cancer is relatively rare, affecting about 5,000 people in the U.S. each
year.

Gardasil, Merck’s top-selling vaccine, already is
approved for prevention of cervical cancer and genital warts in girls and women
aged 9 to 26. It’s also approved for preventing genital warts in boys and men
aged 9 to 26.

The vaccine works by blocking four of the most common strains of human
papilloma virus, or HPV.

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