Date: 2014-06-19
Type of information: Granting of a Market Authorisation in the EU
Product name: Gardasil®
Compound:
Therapeutic area: Cancer - Oncology
Action mechanism: Gardasil®, manufactured by Merck&Co, is a quadrivalent vaccine for protection against cancer of the cervix and the anus, and other genital diseases caused by the human papillomavirus types 6, 11, 16 and 18: precancerous lesions of the cervix (CIN2/3), precancerous lesions of the anus (AIN 2/3), precancerous lesions of the vulva (VIN2/3) and vaginal (VaIN2/3) and genital warts (condyloma acuminata)
Company: Sanofi Pasteur MSD (France)
Disease: prevention of anal cancer
Latest news: * On June, 18 2014, Sanofi Pasteur MSD announced that 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 9 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. The efficacy of Gardasil® against anal disease - anal intraepithelial neoplasia (AIN) and anal cancer - was evaluated in a population of 598 men who have sex with men between 16 and 26 years of age. The primary analysis was conducted in the per-protocol efficacy (PPE) population, which consisted of individuals who received all three vaccinations within one year of enrolment, did not have any major deviations from the study protocol, and were naïve to HPV types 6, 11, 16 and 18 when they started the study and remained free of infection from these four HPV types through one month after receiving their last vaccine dose. The efficacy of Gardasil® in reducing the incidence of anal precancerous lesions grades 2/3 (AIN 2/3) related to vaccine HPV types 6, 11, 16 and 18 was 74.9% (95 % CI: 8.8, 95.4) and 86.6% (95 % CI: 0.0, 99.7) for the anal precancerous lesions grades 2/3 (AIN 2/3) related to the 2 oncogenic vaccine HPV types 16 and 18. The CHMP acknowledged the extrapolation of the efficacy of Gardasil in preventing AIN 2/3 from the MSM population to healthy heterosexual men (HM) and women.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 204-06-18
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
