publication date: Mar. 27, 2015

CHMP Grants Positive Opinion For Gardasil 9 Vaccine

 

The European Committee for Medicinal Products for Human Use granted a positive opinion for Gardasil 9, the first nine-valent HPV vaccine.

The opinion recommends marketing authorization 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 FDA.

Gardasil 9 includes the greatest number of HPV types in any available HPV vaccine. Seven high-risk HPV types, HPV 16, 18, 31, 33, 45, 52 and 58, cause approximately 90 percent of cervical cancer cases and approximately 80 percent of high-grade cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and AIS) worldwide. The two remaining types, HPV 6 and 11, cause 90 percent of genital wart cases.

The CHMP opinion was granted following review of the results from an international clinical program that began in 2007 and included seven trials that evaluated more than 15,000 individuals.

 

The European Medicines Agency granted Orphan Drug Designation to Reolysin, for the treatment of ovarian, fallopian tube and primary peritoneal cancers.

“This is the second jurisdiction where we have gained Orphan Designation for the use of Reolysin in the treatment of these gynecological cancers and our first grant in the European Union,” said Brad Thompson, president and CEO of Oncolytics Biotech Inc., the drug’s sponsor.

The EMA grants Orphan Designation to medicines intended to treat, prevent or diagnose life threatening and … Continue reading 41-12 CHMP Grants Positive Opinion For Gardasil 9 Vaccine

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