FDA accepts sBLA for Gardasil 9 for patients ages 27 to 45 for the prevention of certain cancers and diseases caused by nine human papillomavirus (HPV) types.- Merck Inc.

Merck Inc., has announced that the FDA has accepted for review a new supplemental Biologics License Application (sBLA) for Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. The application is seeking approval for an expanded age indication for Gardasil 9 for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases caused by the nine human papillomavirus (HPV) for an expanded age indication for Gardasil 9 for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases caused by the nine human papillomavirus (HPV) covered by the vaccine. The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 6, 2018. Gardasil 9 is a vaccine indicated in the U.S. in females 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11. Gardasil 9 is also indicated in males 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.