On 26 March 2015, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Gardasil 9, intended for active immunisation against human papillomavirus (HPV) diseases caused by 9 types of HPV.
The applicant for this medicinal product is Sanofi Pasteur MSD SNC.
Gardasil 9 will be available as a suspension for injection. The active substance of Gardasil 9 is made of human papillomavirus type 6, 11, 16, 18, 31, 33, 45, 52, 58 major capsid L1 proteins in the form of virus-like particles (ATC code: J07BM03). The L1 virus-like particles work by triggering a humoral immune response that is effective against the real viruses when the body is exposed to them. The L1 virus-like particles cannot infect cells, reproduce or cause disease.
The benefits with Gardasil 9 are its ability to protect against 9 HPV types that are known to cause approximately: 90% of cervical cancers, more than 95% of adenocarcinoma in situ, 75-85% of high-grade cervical intraepithelial neoplasia, 85-90% of HPV-related vulvar cancers, 90-95% of HPV-related high-grade vulvar intraepithelial neoplasia, 80-85% of HPV-related vaginal cancers, 75-85% of HPV-related high-grade vaginal intraepithelial neoplasia, 90-95% of HPV-related anal cancer, 85-90% of HPV-related high-grade anal intraepithelial neoplasia, and 90% of genital warts.
The most common side effects of Gardasil 9 are headache, and pain, swelling and erythema at the injection site.
The full indication is: “Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases: i) premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types; ii) Condyloma acuminate caused by specific HPV types. The use of Gardasil 9 should be in accordance with official recommendations".
Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing uthorisation has been granted by the European Commission.