Merck & Co., Inc. announced that the Food and Drug Administration (FDA) has accepted for standard review a supplemental Biologics License Application (sBLA) for Gardasil.
The sBLA includes data on protection against vaginal and vulvar cancer caused by HPV types 16 and 18 and data on immune memory. Under the Prescription Drug User Fee Act (PDUFA), for standard sBLAs filed in 2007, the FDA's goal is to review and act on 90 per cent of sBLAs within 10 months of receipt. Merck anticipates action by the FDA in the first quarter of 2008.
Cross protection data were also included in this sBLA. These data are being reviewed as a separate file with a submission date of June 1 which is based on the receipt of an additional user fee. As with all sBLAs, within 60 days of submission the FDA will determine whether it will accept this application for review.
Gardasil is the world's first cervical cancer vaccine, and 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 precancers (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.
Gardasil helps protect against the four HPV types that cause the most HPV disease. HPV types 16 and 18 account for approximately 70 per cent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), vulvar and vaginal precancers (VIN 2/3 and VaIN 2/3), and for 50 per cent of grade 2 cervical lesions (CIN 2). HPV 6 and 11 cause approximately 90 per cent of genital wart cases. These four types of HPV also cause approximately 35 to 50 percent of all low-grade cervical, vulvar and vaginal lesions (CIN I, VIN I and VaIN I).