Sanofi Pasteur Files E.U. Application To Update Gardasil License To Include Prevention Of Vulvar, Vaginal Cancers

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology;  Regulatory Affairs / Drug Approvals
Article Date: 09 Oct 2007 - 8:00 PST

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Sanofi Pasteur on Thursday in a statement said the European Medicines Agency is reviewing its application for extended approval of Merck's human papillomavirus vaccine Gardasil to help prevent vulvar and vaginal cancers caused by HPV strains 16 and 18, Reuters reports (Reuters, 10/4). Sanofi Pasteur is a joint company of Merck and Sanofi-Aventis and markets Gardasil in Europe.

Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with HPV strains 16 and 18 cause about 90% of genital wart cases among women not already infected with these strains (Kaiser Daily Women's Health Policy Report, 9/13).

Merck in June announced that FDA has accepted its application for extended approval of Gardasil to help prevent vaginal and vulvar cancers. A study published in May in the Lancet found that after three years of follow-up study, Gardasil was 71% effective in preventing vaginal and vulvar cancers related to HPV strains 16 and 18 among women who previously had been exposed to HPV strains 6, 11, 16 and 18. It was 100% effective among women who previously had not been exposed to those strains. The vaccine was not effective in fighting vaginal or vulvar lesions that already had formed, according to the study (Kaiser Daily Women's Health Policy Report, 6/22).

Sanofi Pasteur estimated that about 30,000 new cases of HPV-related vulvar and vaginal lesions are diagnosed each year in Europe. In addition, vulvar and vaginal cancers represent about 6% of all gynecological cancers in the United Kingdom. Patrick Poirot, vice president for medical and scientific affairs at Sanofi Pasteur, said, "We have developed Gardasil as a complete offer against a wide range of diseases that affect several genital organs" (Sanofi Pasteur release, 10/4).

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