Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of KAFTRIO® (ivacaftor / tezacaftor / elexacaftor) in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation worldwide.
26.03.2021 - 12:25:13
Vertex Receives CHMP Positive Opinion for KAFTRIO® in Combination With Ivacaftor to Treat People With Cystic Fibrosis With At Least One F508del Mutation. If the European Commission follows the recommendation, the majority of people with CF in Europe will be eligible for the medicine.
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