Vertex Pharmaceuticals, Inc. (VRTX), a leading biotechnology firm, announced on Thursday that Health Canada has agreed to review its New Drug Submission (NDS) for vanzacaftor/tezacaftor/deutivacaftor. This once-daily, triple combination therapy targets individuals aged 6 years and older with cystic fibrosis (CF) who possess at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The NDS will undergo a coordinated review alongside assessments by Canadian Health Technology Assessment (HTA) organizations, including Canada's Drug Agency (CDA) and the Institut national d'excellence en santé et en services sociaux (INESSS) in Quebec.
Additionally, vanzacaftor is currently under regulatory examination in several other regions, including the United States by the Food and Drug Administration (FDA) and the European Union by the European Medicines Agency (EMA).
