Merck & Co. (NYSE:MRK) announced that the U.S. Food and Drug Administration did not approve the company's application to expand the use of Gardasil to include women between the ages of 27 and 45.
Gardasil, a cervical cancer vaccine, was previously approved by the FDA in 2006 for women between the ages of 9 and 27 and the non-acceptance of the expanded use does not affect that approval.
The FDA stated in a letter to Merck that it had completed its review and had found "issues" that prevented the agency from approving the expanded use within the expected review time frame. Merck expects to respond to the FDA in July with answers to the agency's concerns.
Merck has already released a study in November 2007 that found that women over the approved age of 27 benefited from Gardasil HPV. The company "produced data showing that the vaccine prevented 91 percent of cases of persistent infection, minor cervical abnormalities, precancers and genital warts caused by 4 strains of sexually transmitted HPV."
FDA approval for expanded use would increase Merck's share of what is already a multi-billion dollar market.
[Source: YahooNews]
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