FDA approves Gardasil as a treatment for cervical cancer

Merck & Co. has announced that the U.S. Food and Drug Administration (FDA) approved Gardasil as a treatment for cervical cancer, vulvar and vaginal pre-cancers caused by HPV types 16 and 18 and to prevent low-grade and pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18.

In the United States, approximately 10,000 women are diagnosed with cervical cancer every year, and an average of 10 women die each day from the disease.

The FDA has approved Gardasil for the prevention of cervical cancer; cervical pre-cancers, adenocarcinoma in situ and vaginal pre-cancers caused by HPV types 16 and 18. Gardasil is also approved for the prevention of genital warts and low-grade cervical lesions caused by HPV types 6, 11, 16 and 18. Gardasil is approved for 9- to 26-year-old girls and women.

"Merck is proud to be the leader in cervical cancer vaccine research and development," said Richard T. Clark, chief executive officer and president, Merck & Co., Inc. "Bringing forward this life-saving scientific advance is yet another testament to Merck's long-standing mission to research and develop novel vaccines and medicines that can greatly improve public health."

Gardasil is designed to prevent the majority of HPV-related clinical diseases, those caused by HPV 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancers.

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. All four types cause abnormal Pap test results; the lesions caused by types 6 and 11 are clinically indistinguishable from pre-cancerous lesions caused by types 16 and 18.

"Gardasil is a major health breakthrough - the first vaccine specifically designed to prevent cancer - and is approved to prevent not only cervical cancer but also genital warts," said Kevin Ault, MD, associate professor, Department of Gynecology and Obstetrics, Emory University School of Medicine, and clinical study investigator for Gardasil. "Use of Gardasil can help significantly reduce the human and economic burden of cervical cancer, pre-cancerous or low-grade lesions and genital warts caused by HPV 6, 11, 16 and 18 in the United States, and the rest of the world, in this generation and future generations."

In clinical studies, Gardasil prevented 100 percent of HPV 16- and 18 -related cervical cancer in women not previously exposed to the relevant HPV types The efficacy of Gardasil, which includes results from an HPV-16 prototype of Gardasil, was evaluated in four placebo-controlled, double-blind, randomized Phase II and Phase III clinical studies. Together, the Phase II and III studies evaluated 20,541 women aged 16 to 26 years. Study participants were followed for up to five years after enrollment.

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