CFI is pleased to confirm that the European Commission (EC) has granted approval for the label expansion of Kaftrio for the treatment of children with cystic fibrosis (CF) aged 2 to 5 years old who have at least one F508del mutation in the CFTR gene.  

As a result of the existing reimbursement agreement in Ireland (the 2017 portfolio/pipeline agreement) eligible patients in Ireland will likely have access to this extension of Kaftrio in early 2024  - once it has be uploaded to the HSE Hi-Tech Hub. CFI will keep you updated when the HSE informs us of an exact date. 

This welcome decision by the EC follows on from the approval of the CHMP committee of the EMA in July, previously reported by CFI.

No one left behind 

Cystic Fibrosis Europe, of which CFI is a member, will continue to urge the EMA to extend the license for Kaftrio to maximise access to this important drug therapy for all those who have the potential to benefit, including for those with rare mutations, and to support the development of further new and innovative therapies.