Merck & Co recently announced that the US Food and Drug Administration (FDA) has accepted, and designated for priority review, the supplemental Biologics License Application (sBLA) for its recombinant human papillomavirus quadrivalent vaccine (Gardasil) for potential use in women aged 27 through 45. A priority review 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% of BLAs designated for priority review within 6 months of receipt.
The vaccine is currently indicated for girls and women 9 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.