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Merck seeks expanded use for Gardasil


Published: April 17, 2007 at 1:47 PM
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WHITEHOUSE STATION, N.J., April 17 (UPI) -- U.S. firm Merck said Tuesday it is seeking expanded approval of its human papillomavirus vaccine Gardasil for vaginal and vulvar cancers.

To support the filing, the company said it has submitted to the Food and Drug Administration new efficacy data showing some protection against additional strains of the HPV virus types causing more than 10 percent of cervical cancers, as well as data on the vaccine's protection against vaginal and vulvar cancer and on the treatment's "immune memory."

Merck said it will learn within 60 days whether its biologic application has been accepted by the FDA for review, and if so, approval of Gardasil for the additional uses could come within 10 months of that time.

Gardasil was approved last year for use in girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18,, and other uses including prevention of cervical pre-cancers, vulvar pre-cancers and vaginal pre-cancers.

HPV types 16 and 18 are to blame for roughly 70 percent of all cervical cancers, non-invasive cervical cancers, vulvar and vaginal pre-cancers, and for 50 percent of grade 2 cervical lesions, Merck said.



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