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GARDASIL® 9, New HPV Vaccine from Sanofi Pasteur MSD Granted Positive Opinion by European Committee for Medicinal Products for Human Use

France (ots/PRNewswire)

European Committee for Medicinal Products for Human Use (CHMP) granted

positive opinion for GARDASIL 9, the first 9-valent HPV vaccine

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.

To view the Multimedia News Release, please click:

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.



Contact: Sylvia Martin-Jarrand, Sanofi Pasteur MSD, Tel:
+33-4-37-28-40-55, Mob: +33-6-74-85-19-63,

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