European Regulatory Body Approves Sanofi Pasteur MSD’s Gardasil

European Regulatory Body Approves Sanofi Pasteur MSD’s GardasilEuropean regulators have approved Sanofi Pasteur MSD’s cervical cancer vaccine, Gardasil, for the prevention of anal cancer.

The European Commission granted marketing authorisation to Gardasil to be used in the prevention of anal precancerous lesions and anal cancers causally related to certain oncogenic human papillomavirus types in both males and females.

Roughly 6,800 patients are estimated to be diagnosed with anal cancer in Europe every year, of which approximately 75-80% of diagnosis are attributable to HPV types 16 and 18.

Sanofi Pasteur MSD, a joint venture between Sanofi and Merck & Co, noted that, according to population-based studies, anal cancers are more common in women than in men.  The occurrence of anal cancer is high amongst men who have sex with men, however the Sanofi Pasteur MSD cited a study which estimated that 53% of male anal cancers occurred in heterosexuals.

The president of Sanofi Pasteur MSD, Paul Kress, commented that the new indication for Gardasil, which provides “a unique prevention tool for such a serious oncological disease,” further “reinforces the need for widespread vaccination of both males and females against HPV.”  He noted that this is especially important as “there are currently no other routine measures or screening programs available for prevention of anal cancers.”

Gardasil is already approved for the prevention of cervical cancer and premalignant genital lesions causally related to certain oncogenic Human Papillomavirus (HPV) types in females.  All European countries currently implement vaccination programmes for girls, although from September Austria will vaccinate both boys and girls.  Launched in 2006, Gardasil is the most widely used HPV vaccine worldwide, with roughly 152 million doses distributed to date.


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