April 6, 2011 / 9:51 PM / in 7 years

UPDATE 1-Merck says FDA turns down Gardasil for older women

* No US approval for use in older women

* Gardasil label updated

LOS ANGELES, April 6 (Reuters) - U.S. regulators have turned down Merck & Co Inc’s (MRK.N) bid to extend use of its cervical cancer vaccine Gardasil for women between the ages of 27 to 45.

Merck said on Wednesday that the Food and Drug Administration concluded that Gardasil has not been shown to prevent HPV-related cervical cancers in women over the age of 26 and the drug’s label has been updated to reflect that decision.

Gardasil is approved for use in girls and young women 9 through 26 years of age for prevention of cervical, vulvar, vaginal and anal cancers.

    It fights infection with the sexually transmitted human papilloma virus (HPV), best known as the primary cause of cervical cancer. HPV also can lead to cancers of the anus, penis, head and neck. (Editing by Carol Bishopric)

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