Dive Brief:
- Gardasil has been approved in the EU for prevention of anal precancerous lesions and HPV-related anal cancers.
- The approval extends to use in men and women.
- Globally, Gardasil is the most widely used HPV vaccine, with approximately 152 million doses distributed since 2006.
Dive Insight:
The approval of Gardasil in the EU will expand its use significantly. Currently it is used for the prevention of HPV and related cervical cancer in girls (and soon boys in Austria); however, now it can also be used in adult men and women to prevent other HPV-related diseases, specifically anal cancer.
Because 75 to 80% of anal cancers are due to HPV types 16 and 18, Gardasil’s therapeutic range is broad. As a quadrivalent HPV vaccine it helps to protect against cervical cancer, anal cancer, precancerous lesions and genital warts. Currently about 6,800 cases of anal cancer occur in Europe each year. Clinical trials have shown a high level of preventive efficacy against anal cancer in men who have sex with men.