Vertex’s Kaftrio (ivacaftor/tezacaftor/elexacaftor) + Ivacaftor Receives CHMP’s Positive Opinion for the Treatment of Cystic Fibrosis in Children Aged 6 to 11

November 15, 2021 Auto Bot CHMP, Cystic fibrosis, regulatory, Vertex 0

Shots:

  • The EMA’s CHMP has adopted a positive opinion for the label extension of Kaftrio in combination with ivacaftor to treat CF in patients aged 6 to11 yrs. who have at least one F508del mutation in a CFTR gene
  • The combination therapy showed improvements in lung function, sweat chloride & respiratory symptoms, safety & tolerability profile were consistent with that observed in patients aged ≥12yrs.
  • Kaftrio + ivacaftor is approved in the EU for the treatment of CF in patients aged ≥12yrs. who have at least one copy of the F508del mutation in the CFTR gene

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