WHITEHOUSE STATION, N.J., March 19, 2008 - Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted, and designated for priority review, the supplemental Biologics License Application (sBLA) for Gardasil [Human Papillomavirus Quadrivalent] (Types 6, 11, 16, 18) Vaccine, Recombinant] for the potential use in women aged 27 through 45. A priority designation is intended for products or indications that address unmet medical needs. Under the Prescription Drug User Fee Act, the FDA's goal is to review and act on 90 percent of BLAs designated as priority review within six months of receipt.
Gardasil is currently indicated for girls and women nine through 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18. Women remain at risk for newly acquired HPV infections and developing HPV-related diseases throughout their lifetime.
Source: Merck & Co., Inc.