Sanofi Pasteur MSD has announced that the European Commission has granted a new indication for Gardasil®, for the prevention of anal cancer and anal precancerous lesions caused by specific oncogenic HPV types in both females and males.
The European Commission has granted marketing authorisation for the use of Gardasil for the prevention of anal precancerous lesions and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types in both males and females.
Gardasil is already approved from nine years of age for the prevention of cervical cancer and premalignant genital lesions (cervical, vulvar and vaginal) causally related to certain oncogenic Human Papillomavirus (HPV) types in females. It is also approved for the prevention of genital warts causally related to specific HPV types in both males and females.
HPV is a virus that causes a number of diseases and cancers, including cervical cancer in females and anal cancer in both males and females. This new indication acknowledges the properties of Gardasil®, targeting the high-risk HPV types 16 and 18 which are causing the vast majority of anal cancers.
Dr Jean-Paul Kress, President of Sanofi Pasteur MSD, said: “Thanks to the new indication for anal cancer, Gardasil provides today a unique prevention tool for such a serious oncological disease.
“The possibility to prevent anal cancer further reinforces the need for widespread vaccination of both males and females against HPV, especially since there are currently no other routine measures or screening programs available for prevention of anal cancers.”
Gardasil it is the most widely used HPV vaccine worldwide with approximately 152 million doses distributed to date.