LYON, France, June 17, 2015 /PRNewswire/ --
The European Commission grants marketing authorization for GARDASIL 9, the only 9-valent HPV vaccine
Sanofi Pasteur MSD announced today that the European Commission has granted marketing authorization for GARDASIL 9. GARDASIL 9 is 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 or anus and also against genital warts (Condyloma acuminata) caused by the HPV types covered by the vaccine.
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The approval of GARDASIL9 follows the positive opinion of the European Committee for Medicinal Products for Human Use (CHMP) granted on March 27th 2015.
"We are delighted to receive the EU Commission approval for this important vaccine that provides an extraordinary opportunity to further prevent cancer in women and men throughout Europe," said Dr Jean-Paul Kress, President of Sanofi Pasteur MSD. "This vaccine is a significant step forward for public health; by vaccinating boys and girls we can prevent not only 90% of cervical cancers but also implement effective immunization programs to address other types of HPV related diseases such as anal, vulvar and vaginal cancers for which there is no current systematic screening," he concluded.
GARDASIL 9 includes more HPV types than any currently 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, 90% of HPV related anal cancer and 80% of high-grade cervical lesions (cervical precancers defined as CIN 2, CIN 3 and AIS) worldwide. The two low-risk types, HPV 6 and 11, cause 90% of genital wart cases.[i]
The marketing authorization is supported by a comprehensive clinical program initiated in 2007; seven trials evaluated more than 15,000 individuals across 30 countries. GARDASIL 9 was shown to be 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 addition, the vaccine was shown to elicit antibody responses against HPV types 6, 11, 16 & 18 that were non-inferior to Gardasil®, the leading HPV vaccine.
GARDASIL 9 will be commercialized in Western European countries by Sanofi Pasteur MSD (a joint venture between MSD and Sanofi Pasteur), in the United States and Canada by Merck, and in other countries (including Eastern Europe) by MSD.
i. Hartwig et al. Burden of HPV related cancers and precancerous lesions in women and men in Europe: potential additional benefit of a 9-valent compared to the 4-valent vaccine in Europe. IPV congress 2014, Seattle. Poster presentation.
SOURCE Sanofi Pasteur MSD