CHMP positive opinion for GSK's Cervarix two-dose schedule
UK pharma giant GlaxoSmithKline (LSE: GSK) says that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending marketing authorization for a two-dose schedule in nine to 14-year-old girls for its cervical cancer vaccine, Cervarix (Human papillomavirus bivalent [types 16 and 18] vaccine, recombinant).
The EU licence application is based on the results of a Phase III study (HPV-070) which showed that two doses of the vaccine in girls aged nine to fourteen years provide an immunogenicity matching the currently licensed three-dose schedule in 15 to 25-year-olds (The Pharma Letter November 4).
Should expand patient population
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