EFN

Merck & Co. has come to another setback in trying to widen the use of Gardasil. This is the second time the FDA has not approved this vaccine. The cervical cancer vaccine, Gardasil, was denied by the US Food and Drug Administration for older women ages 27 to 45.

The FDA told Merck in June that it had completed their review of the application and issues were holding it back from being approved within the review period. Merck did come back to the FDA with more information, but it was not enough to get approval. The first application submitted had data from patients from the past 24 months. The FDA wants additional data for a four-year study of Gardasil. Once the 48-month study is completed, the FDA will try to approve it again in the fourth quarter of 2009.

Gardasil was approved first in 2006 for women between ages 9 and 26. Merck is now trying to get the vaccine approved for older women. Gardasil is used for prevention against HPV (human papillomavirus), which causes cervical cancer. Gardasil is more effective in younger women who have not yet been exposed to HPV. The effectiveness is naturally lower in older women and because of this Merck could have a hard time convincing insurers to cover Gardasil in the older age group. Merck is determined to approve the use of Gardasil for older women who still remain at risk for the HPV throughout their lifetime.