BRIEF—Health Canada approval for Trikafta in six to 11 year-olds

Health Canada has granted Marketing Authorization for the expanded use of Vertex Pharmaceuticals’ Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages six through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

With this announcement, approximately 500 Canadians with CF ages six-11 are now eligible for Trikafta.

As a result of this approval, an additional dosage strength of Trikafta tablets is now available (elexacaftor 50mg/tezacaftor 25mg/ivacaftor 37.5mg and ivacaftor 75mg).

Vertex has also submitted this indication to both the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en santé et en services sociaux (INESSS) in Québec for Health Technology Assessments.