Merck has submitted a sBLA for Gardasil to the FDA to update the labeling to include efficacy data showing protection against additional cervical cancer causing HPV types responsible for more than 10% of cervical cancers, vaginal and vulvar, and data on immune memory.

Gardasil is approved for use in girls and women ages 9 to 26 for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18.

Under the Prescription Drug User Fee Act (PDUFA), for standard supplemental BLAs filed in 2007, the FDA’s goal is to review and act on 90% of BLAs within 10 months of receipt.