Gardasil gets FDA Designated Priority Review

WHITEHOUSE STATION, N.J. The Food and Drug Administration recently accepted Merck’s Gardasil for priority review for older women, according to published reports.

Gardasil, officially called Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant, is currently indicated for females from age nine to 26 for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV.

The FDA is now placing Gardasil under designated priority review for women ranging from ages 27 through 45. Acceptance of the supplemental Biologics License application under priority review displays that the FDA will take up to 6 months to review it, rather than the usual 10 months it takes to review a new supplement.