EC Approves Kaftrio In Combination With Ivacaftor To Treat Cystic Fibrosis In Children

Vertex Pharmaceuticals Inc. (VRTX) said Tuesday that the European Commission or EC has granted approval for the label extension of Kaftrio in a combination regimen with Ivacaftor, for the treatment of cystic fibrosis or CF in children with gene mutations.

Elexacaftor/tezacaftor/ivacaftor, sold under the brand names Kaftrio in Europe, is a fixed-dose combination medication used to treat cystic fibrosis with a F508del mutation or other mutations, in patients under the age group of 6 to 11 years.

As a result of long-term reimbursement deals in Austria, Northern Ireland, and Denmark, and provisions for access in health care systems such as Germany, eligible patients in these countries will have access to the expanded indication for Kaftrio in a combination regimen with Ivacaftor shortly after the regulatory approval by the EC.

Vertex further said it will continue to work with reimbursement bodies across the EU to ensure access for all eligible patients.

The drug has also been approved by regulatory authorities in New Zealand and Switzerland.

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