US FDA accepts Merck's Gardasil BLA

Merck & Co says that the US Food and Drug Administration has accepted its Biologics License Application for its investigational cervical cancer vaccine Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) and agreed to give it priority review. Such a designation is intended for products that address unmet medical needs and, under the Prescription Drug User Fee Act, for BLAs filed in 2005, the FDA's goal is to review and act on BLAs designated as priorities within six months of receipt. The FDA has set its goal date by June 8. Since submission to the FDA in December, Merck has also filed applications for the agent with additional regulatory agencies including those in the European Union Australia, Mexico, Brazil, Argentina, Taiwan and Singapore.