Merck Wins U.S. Approval for Gardasil Vaccine in Boys

Shannon Pettypiece
Bloomberg
October 16, 2009

[efoods]Merck & Co.’s Gardasil, a vaccine used to prevent cervical cancer in women, won U.S. regulatory approval for preventing genital warts in boys.

The U.S. Food and Drug Administration cleared the vaccine for use in males ages 9 to 26, Merck said today in a statement.

Gardasil protects against a sexually transmitted infection called human papillomavirus, or HPV, that can lead to cervical cancer in women and genital warts and cancer of the penis and anus in men. Gardasil, approved for females ages 9 to 26, is given mostly to school-age girls as a U.S.-recommended routine vaccination. Expanding the shot’s use could revive sales, which declined 5 percent last year, analysts have said.

“This is an important milestone, because the use of Gardasil can now help protect boys and girls and young men and women from certain diseases caused by this common virus,” said Richard Haupt, executive director of Merck Research Laboratories, in the company’s statement.

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