European Committee for Medicinal Products for Human Use (CHMP) granted positive opinion for GARDASIL 9, the first 9-valent HPV vaccine
Lyon, France – March, 27 2015/ PR Newswire/ - Sanofi Pasteur MSD today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted this week a positive opinion recommending the marketing authorisation for GARDASIL 9, a 9-valent HPV vaccine, for active immunization of females and males from the age of 9 years against premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types and genital warts (Condyloma acuminata) caused by specific HPV types.
The CHMP's positive opinion comes after the recent approval of GARDASIL 9 granted by the Food and Drug Administration (FDA, USA).
"We anticipate that, if approved, GARDASIL 9 will represent a major step forward in HPV prevention. GARDASIL 9 has the potential to help prevent over 80% of genital cancers caused by HPV and to reduce the transmission of the 9 HPV types" said Dr Jean-Paul Kress, President of Sanofi Pasteur MSD. "We are delighted that the CHMP has recommended marketing authorisation for GARDASIL 9 and we are looking forward to the European Commission decision", he concluded.
GARDASIL 9 includes the greatest number of HPV types in any available HPV vaccine. The seven high-risk HPV types in GARDASIL 9 (HPV 16, 18, 31, 33, 45, 52 and 58) cause approximately 90% of cervical cancer cases and approximately 80% of high-grade cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and AIS) worldwide. The 2 remaining types, HPV 6 and 11, cause 90% of genital wart cases.
The CHMP opinion was granted following review of the results from a comprehensive clinical program that began in 2007 and included seven trials that evaluated more than 15,000 individuals in more than 11 countries.
The pivotal study recently published in the New England Journal of Medicine1 showed that GARDASIL 9 was 97% effective in preventing high-grade lesions of the cervix, vagina and vulva caused by the 5 additional oncogenic HPV types (31,33,45,52,58) in 16- through 26-year-old girls and women. In addition, the vaccine was shown to elicit antibody responses in females aged 9-26 years against HPV types 6, 11, 16 & 18 that were non-inferior to GARDASIL, the leading HPV vaccine, thereby bridging the efficacy of GARDASIL to GARDASIL 9.
The CHMP's positive opinion will now be reviewed by the European Commission (EC) which has the authority to approve medicines for the European Union.
About GARDASIL® 9
GARDASIL® 9, manufactured by Merck, is the first and only nonavalent HPV vaccine helping to protect females and males against genital diseases and cancers caused by 9 human papillomavirus types (6, 11, 16, 18, 31, 33, 45, 52, 58) causing approximately 90% of cervical cancer cases and approximately 80% of high-grade cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and AIS) worldwide. These seven HPV types also cause 85-90% of HPV-related vulvar cancers, 80-85% of HPV-related vaginal cancers, and 90-95% of HPV-related anal cancers. HPV types 6 and 11 cause approximately 90% of genital warts cases.
Gardasil®, manufactured by Merck, is the only quadrivalent HPV vaccine helping to protect people from genital diseases and cancers caused by the human papillomavirus types 6, 11, 16 and 18: cervical cancer, anal cancer, 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).
Data published since Gardasil® came on the market have confirmed the positive impact of this vaccine on the prevention of genital diseases caused by human papillomavirus types 6, 11, 16 and 18.
Launched nearly 10 years ago in 2006, Gardasil is Western Europe's leading HPV vaccine with over 33 million doses distributed and approximately 178 million doses distributed worldwide to date.
About Sanofi Pasteur MSD http://www.spmsd.com
Sanofi Pasteur MSD is a European joint venture formed between Sanofi Pasteur (the vaccine division of Sanofi) and Merck (known as MSD outside the United States and Canada). Combining innovation and expertise, Sanofi Pasteur MSD is the only European pharmaceutical company dedicated exclusively to the distribution of vaccines. Sanofi Pasteur MSD makes use of the combined expertise resulting from Sanofi Pasteur and Merck's research to focus on the development of new vaccines in Europe in order to produce the most effective, most acceptable and better tolerated vaccines.