Vertex Says Health Canada Accepts NDS For Triple Combination To Treat Cystic Fibrosis

(RTTNews) - Biotechnology company Vertex Pharmaceuticals, Inc. (VRTX) announced Thursday that Health Canada has accepted for review its New Drug Submission (NDS) for vanzacaftor/tezacaftor/deutivacaftor, a once-daily triple combination therapy for people living with cystic fibrosis (CF) ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

The NDS will be part of an aligned review with Canadian Health Technology Assessment (HTA) organizations, Canada's Drug Agency (CDA) and the Institut national d'excellence en sante et en services sociaux (INESSS) in Quebec.

Vanzacaftor is also undergoing regulatory review in multiple other jurisdictions, including by the Food and Drug Administration (FDA) in the U.S. and by the European Medicines Agency (EMA) in the E.U.