Posted by Michael Wonder on 25 Sep 2021
Vertex's supplement to a new drug submission for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene accepted for priority review by Health Canada
22 September 2021 - Vertex Pharmaceuticals today announced its supplement to a new drug submission for Kalydeco (ivacaftor) has been accepted for priority review by Health Canada for the treatment of cystic fibrosis in patients from 4 months to 18 years of age and weighing at least 5 kg with the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.
Ivacaftor is the first medicine to treat the underlying cause of cystic fibrosis in people with specific mutations in the CFTR gene.
