FDA Advisory Committee Supports Approval of GARDASIL® for Prevention of Anal Cancer and AIN in both Men and Women
WHITEHOUSE STATION, NJ - Nov. 17, 2010 - Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.
"We are pleased with the outcome of today's meeting and look forward to continued discussions with the FDA as it evaluates the data for the proposed indication," said Elizabeth Garner, M.D., MPH, director, clinical research, Merck Research Laboratories. "Today's discussion brings us closer to being able to also provide GARDASIL to men and women for the prevention of anal cancer and AIN."
The Committee's input will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in early 2010. The FDA is not bound by the Committee's guidance, but takes its advice into consideration when reviewing vaccines.
The efficacy of GARDASIL against HPV-related anal disease was studied in a population of men who have sex with men because of the known high risk of anal infection and disease that occurs in this group. Merck submitted the sBLA for use of GARDASIL in both men and women because anal cancer affects both men and women and the disease is similar in both genders. Up to 90 percent of anal cancers are caused by HPV, with HPV 16 and 18 causing approximately 80 percent of those cases.
GARDASIL is approved in the U.S. for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts (condylomata acuminata) caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 75 percent of cervical cancer cases, and HPV types 6 and 11 account for approximately 90 percent of genital warts cases. GARDASIL is also approved in the U.S. for use in boys and men ages 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11.
Important information about GARDASIL
GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.
GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, and vaginal cancers; cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.
GARDASIL has not been demonstrated to protect against disease due to HPV types not contained in the vaccine.
Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] protects only against those vulvar and vaginal cancers caused by HPV Types 16 and 18.
Select safety information
GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
GARDASIL is not recommended for use in pregnant women.
The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.
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 deltoid region of the upper arm or in the higher anterolateral area of the thigh. 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.
GARDASIL is approved in 121 countries
GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] (sold in some countries as SILGARD®) has been approved in 121 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.
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