Merck announced the Company has submitted a supplemental Biologics License Application (sBLA) for GARDASIL? [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] to the U.S. Food and Drug Administration (FDA) to update the labeling for GARDASIL, the cervical cancer vaccine.
The new submission for GARDASIL includes efficacy data showing some protection against additional cervical cancer causing HPV types responsible for greater than 10 percent of cervical cancers, data on protection against additional gynecological cancers — vaginal and vulvar, and data on immune memory.
GARDASIL is the world’s first and only 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 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. GARDASIL helps protect against the four HPV types that cause the most HPV disease. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), vulvar and vaginal pre-cancers (VIN 2/3 and VaIN 2/3), and for 50 percent of grade 2 cervical lesions (CIN 2). HPV 6 and 11 cause approximately 90 percent 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).
Within 60 days following submission, the FDA will determine whether it will accept for review Merck’s application as submitted. 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 percent of BLAs within 10 months of receipt.
During a decade of clinical trials for GARDASIL, more than 25,000 individuals have been studied. “GARDASIL has been strongly embraced by the medical community and by patients, and we are excited to submit these additional data. Merck is pleased to also file for indications to help protect against two additional gynecological cancers to further extend the value that Gardasil offers to females,” said Beverly J. Lybrand, vice president and general manager, HPV Franchise, Gardasil, Merck Vaccines. “We look forward to working with the FDA as they review our application.”