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Vertex Pharma: CHMP Adopts Positive Opinion For Label Extension Of KAFTRIO To Include 6-11 Age Group

Vertex Pharmaceuticals Incorporated (VRTX) said the European Medicines Agency's CHMP adopted a positive opinion for the label extension of KAFTRIO in a combination regimen with ivacaftor, for the treatment of cystic fibrosis in patients ages 6 through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane
conductance regulator gene.

KAFTRIO in combination with ivacaftor is approved in the European Union for the treatment of cystic fibrosis in patients ages 12 years and older who have at least one copy of the F508del mutation in the CFTR gene.

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