Supplier News Breaks Archives
Merck's Gardasil approved for new indications
December 27th, 2010
WHITEHOUSE STATION, N.J. – Gardasil, Merck's vaccine for human papillomavirus (HPV), has been approved by the Food and Drug Administration for the prevention of anal cancer and anal intraepithelial neoplasia (AIN).
The drug maker said the FDA cleared the new indications for Gardasil to treat anal cancer caused by HPV types 16 and 18 and to treat AIN grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18 in males and females ages 9 through 26.
"We are pleased that with this new indication for Gardasil against HPV-related anal cancer and disease, both males and females can be protected against cancer, which further reinforces the importance of vaccinating both genders," commented Richard Haupt, executive director of Merck Research Laboratories. "Gardasil is the only HPV vaccine available for use in both males and females, and the only one indicated to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV."
Merck reported that in the United States, an estimated 75% to 80% of males and females will be infected with HPV in their lifetime. For most, HPV will clear on its own, but for those who don't clear certain types HPV can cause cervical, vaginal and vulvar cancers in women and anal cancer and genital warts in men and women.
It's estimated that HPV types 16 and 18 account for about 80% of anal cancers, 75% of cervical cancers, 70% of vaginal cancers and 40% to 50% of vulvar cancers, according to Merck, which added that HPV types 6 and 11 cause approximately 90% of all genital warts cases.
The company said anal cancer affects both men and women, with about 60% of cases occurring in women. According to the American Cancer Society, it's estimated that 2,000 men and more than 3,000 women will have been diagnosed with anal cancer in 2010.