Sanofi Pasteur MSD has submitted cross protection data to the European Medicines Agency (EMEA) to update the licence for the Human Papillomavirus vaccine Gardasil?.
The new data come from large phase III clinical studies, including more than 17,000 women and show that Gardasil? provides benefits against pre-cancerous and potentially pre-cancerous cervical lesions caused by additional virus types not directly targeted by the vaccine.
Pre-cancerous lesions are the obligate precursor of cervical cancer; their prevention is the best proof for the prevention of cervical cancer. The additional virus types cause more than 10% of cervical cancer and substantial proportions of pre-cancerous and potentially pre-cancerous cervical lesions.
According to the current marketing authorisation in the European U nion, Gardasil? is indicated for the prevention of cervical carcinoma (cervical cancer), high grade cervical dysplasia (pre-cancerous cervical lesions), high grade vulvar dysplastic lesions (pre-cancerous vulvar lesions) and external genital warts (condyloma acuminata) caused by Human Papillomavirus types 6, 11, 16 and 18. In addition, Gardasil? is efficacious in the prevention of potentially pre-cancerous lesions caused by the virus types 6, 11, 16 and 18.