Merck Provides Update on Status of Supplemental Biologics License Applications (sBLA) for GARDASIL®
WHITEHOUSE STATION, N.J.- Merck & Co., Inc. announced today that the Food and Drug Administration (FDA) has accepted for standard review a supplemental Biologics License Application (sBLA) for GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]. 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 percent 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 percent 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 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).
Selected important information about GARDASIL
GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine. The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.
Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to other HPV types.
In clinical studies for GARDASIL, vaccine-related adverse experiences were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).
Dosage and administration for GARDASIL
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.
Access to GARDASIL
There is broad private and public health insurance coverage for GARDASIL. Health plans covering approximately 98 percent of privately-insured lives in the U.S. (currently more than 140 insurance plans) have implemented coverage for GARDASIL; however, individual benefit coverage and rates provided by health plans may vary.
GARDASIL was also added to the Vaccines for Children (VFC) Program on November 1, 2006, providing coverage for many who do not have private health insurance. To date, all 55 immunization projects have adopted GARDASIL and most are accepting provider orders. Merck also has a patient assistance program for vaccines. Through this program, currently available in private physicians’ offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals ages 19 and older who are uninsured and who are unable to afford vaccines.
Worldwide availability of GARDASIL
GARDASIL (sold in some countries as SILGARD®) has been approved in more than 70 countries including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil. Additional applications for GARDASIL are currently under review with regulatory agencies in many more countries around the world.
About HPV disease
In the United States, approximately 20 million people are infected with HPV, and approximately 80 percent of females will have acquired HPV by age 50. For most people, HPV goes away on its own; however in some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year. It is estimated that in 2007, there will be approximately 11,150 new cases of cervical cancer and 3,700 deaths in the United States. In the U.S., vaginal and vulvar cancer accounts for appropriately 3 percent and 4 percent of cancers in the female reproductive organs respectively; approximately 6,000 cases of vulvar or vaginal cancer are diagnosed annually in the U.S. Certain low-risk types of HPV cause genital warts and can lead to abnormal Pap results. Approximately one million cases of genital warts occur each year in the United States and an estimated 32 million cases occur worldwide. Additionally, there are an estimated 4.7 million abnormal Pap results that require follow-up each year in the United States. At least 3 million of these results are caused by some type of HPV.
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.
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