Merck Submits Data To Widen Gardasil Use

Pharmalot

January 14, 2010

The Gardasil grope continues. Merck gave the FDA new data to win approval to market its HPV vaccine to women between the ages of 27 and 45. Gardasil is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. The vaccine is also approved to prevent genital warts in males of the same age.

Merck has been trying for some time to win FDA approval to market Gardasil to more women, but has so far been frustrated. In June 2008, the agency bounced its request to treat women between ages of 27 and 45, which contributed to a slowdown in sales (background here). Early last year, the FDA again withheld approval and asked Merck to submit data when a 48-month study on a test group has been completed.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.