FDA approves Trikafta for children aged 6 to 11 with cystic fibrosis

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Sumary of FDA approves Trikafta for children aged 6 to 11 with cystic fibrosis:

  • The FDA has expanded use of elexacaftor/tezacaftor/ivacaftor for children aged 6 to 11 years with cystic fibrosis with certain mutations, according to a press release from Vertex Pharmaceuticals..
  • The new approval includes children who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive to elexacaftor/tezacaftor/ivacaftor (Trikafta) based on in vitro data..
  • An additional dosage strength is now available — elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 75 mg and ivacaftor 75 mg) in connection with this approval, according to the release….

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