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.