Sanofi Pasteur MSD's Gardasil becomes first HPV vaccine approved in Europe

French vaccines developer Sanofi Pasteur, part of the Sanofi-Aventis group, says that its product Gardasil (human papilloma virus vaccine) has been granted a European license for the prevention of cervical cancer and other HPV diseases before and beyond cervical cancer. The vaccine targets the four types of the virus - 6, 11, 16 and 18 - which together account for the vast majority of genital HPV-related diseases.

In the regulatory filings for the agent, which included data from more than 25,000 women, Gardasil prevented up to 100% of cervical cancer, precancerous and potentially precancerous cervical lesions, vulvar and vaginal precancerous lesions and genital warts due to HPV types 6, 11, 16 and 18. High and consistent efficacy has been observed for five years and is expected to be long-lasting. Early laboratory data suggest that Gardasil may also prevent infection with HPV types 31 and 45, which are not directly targeted by the vaccine (Marketletter September 11).

Despite screening for early detection, cervical cancer remains the second most common cause of death from cancer (after breast cancer) among women aged between 15 and 44 years in Europe, where approximately 33,500 women are diagnosed with, and 15,000 die from, cervical cancer each year. Hundreds of thousands of women are diagnosed with cervical, vulvar or vaginal pre-cancer and genital warts are a growing problem in the region, Sanofi noted.