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Vertex Pharma (VRTX) Granted European CHMP Positive Opinion for KALYDECO for Children/Adolescents with CF and R117H Mutation in CFTR Gene
May 1, 2020 5:50 AM EDTVertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of KALYDECO® (ivacaftor), to include the treatment of children and adolescents with cystic fibrosis (CF), ages 6 months and older weighing at least 5 kg who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Todays announcement is important for young people with CF, as early intervention and treatment of this devastating and progressive disease is key to... More
