Vertex Pharma (VRTX) Granted European CHMP Positive Opinion for KALYDECO for Children/Adolescents with CF and R117H Mutation in CFTR Gene

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Go back to Vertex Pharma (VRTX) Granted European CHMP Positive Opinion for KALYDECO for Children/Adolescents with CF and R117H Mutation in CFTR Gene

Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) for Children and Adolescents With Cystic Fibrosis Between the Ages 6 Months and 18 Years With the R117H Mutation in the CFTR G

May 1, 2020 3:00 AM EDT

- If approved, KALYDECO® (ivacaftor) will be the first and only medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation, the most common residual function mutation, as young as 6 months of age -

LONDON--(BUSINESS WIRE)-- Vertex 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... More