Merck announced today the Company has submitted a supplemental Biologics License Application (sBLA) for GARDASIL(R) (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."
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.
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 non-vaccine HPV types.
Vaccine-related adverse experiences that were observed in clinical trials 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).
Access to GARDASIL
There is broad private and public health insurance coverage for GARDASIL. Health plans covering approximately 97 percent of privately-insured lives in the U.S. (currently more than 120 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, 53 out of 55 immunization projects (which cover 94 percent of the public sector birth cohort in the U.S.) have adopted GARDASIL and many have already begun to accept provider orders.
Merck has also initiated a new 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(R)) has been approved in more than 60 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 more than 50 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.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com
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