More data sought for Merck’s Gardasil in older women

NEW YORK (Reuters) - U.S. health regulators want longer-term data on the use of Merck & Co’s Gardasil cervical cancer vaccine in an older group of women before they will approve the vaccine for those women, the drugmaker said on Friday.

The U.S. Food and Drug Administration has issued a second complete response letter to Merck regarding its application to expand use of Gardasil for women ages 27 through 45, after also declining to approve Merck’s request in June.

The agency has now recommended that Merck submit data when a 48-month study has been completed. Merck’s initial application included data collected through an average of 24 months.

Merck expects to respond to the agency in the fourth quarter.

Gardasil, one of Merck’s most important products, is approved for use in girls and women ages 9 through 26. The FDA letter does not affect use in the younger group or Merck’s application to expand use to males, the company said.

The drugmaker backed its overall 2009 sales and earnings targets. It said it will update other elements of its forecast on its February 3 earnings conference call. In December, Merck forecast Gardasil sales of $1.4 billion to $1.6 billion for 2009.

(Reporting by Lewis Krauskopf, editing by Dave Zimmerman)


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