The supplemental New Biologics License Application (sBLA) for Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant; Merck) has been accepted and granted Priority Review by the Food and Drug Administration (FDA).
The Gardasil 9 vaccine is already indicated for 9 types of HPV in men and women ages 9 through 26. The new sBLA is seeking approval to expand the age range to 27 though 45. Specifically, the vaccine protects against the following: HPV 16, 18, 31, 33, 45, 52, 58, and types 6 and 11 which cause genital warts.
“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,” said Dr. Alain Luxembourg, director of clinical research, Merck Laboratories.
Gardasil 9 is not a substitute for routine cervical or anal cancer screening; not for protection against disease from vaccine HPV types through exposure to sexual activity or diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58; not for treating external genital lesions, cervical, vulvar, vaginal, and anal cancers, CIN, VIN, VaIN, or AIN. Gardasil 9 may not protect all vaccine recipients.
A Prescription Drug User Fee Act (PDUFA) target action date of October 6, 2018, has been set by the agency.
For more information call (800) 672-6372 or visit Gardasil.com.