Posted by Michael Wonder on 03 May 2023
Vertex announces US FDA approval for Kalydeco (ivacaftor) to treat eligible infants with CF ages 1 month and older
3 May 2023 - First and only CFTR modulator approved for this age group.
Vertex Pharmaceuticals today announced the US FDA approved Kalydeco (ivacaftor) for use in children with cystic fibrosis ages 1 month to less than four months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on clinical and/or in vitro assay data.
