The FDA granted priority review to a supplemental biologics license application that seeks approval of the HPV 9-valent vaccine, recombinant, for use among women and men aged 27 to 45 years for the prevention of HPV-related cancers.
The FDA set an action date of Oct. 6.
The HPV 9-valent vaccine (Gardasil 9, Merck) is indicated for use among males and females aged 9 to 26 years for the prevention of HPV-related cervical, vulvar, vaginal and anal cancers; precancerous or dysplastic lesions; and genital warts.
The priority review designation applies to women and men aged 27 to 45 years.
“Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases,” Alain Luxembourg, MD, PhD, director of clinical research at Merck, said in a company-issued press release. “We look forward to working with the FDA on the review of this application for Gardasil 9, which, if approved, would enable more people to have access to the vaccine.”