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GEN News Highlights : Jun 25, 2008

FDA Hits Merck & Co. with Double Whammy for Gardasil Label Extensions

Agency denied approval in nonvaccine HPV types and identified questions regarding the use of the vaccine in older women.

FDA issued negative reviews of two sBLAs from Merk & Co. related to its HPV vaccine, Gardasil. The agency decided that submitted data did not support approving Gardasil in nonvaccine HPV types.

In a separate complete response letter, FDA also found problems with the firm’s application to extend the use of the treatment to women between 27 and 45 from its current indication covering ages 9 to 26.

Merck submitted the sBLA to expand Gardasil’s reach to older women in January, and in March the FDA designated the submission a priority review. Today’s letter from the FDA notes that the identified problems would not allow it to approve the therapy within the review timeframe. Merck expects to respond to the agency in July.