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Vertex Announces Health Canada Acceptance of New Drug Submission for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-in-Class Triple Combination Treatment for Cystic Fibrosis
Vertex Announces Health Canada Acceptance of New Drug Submission for Vanzacaftor/Tezacaftor/Deuti...
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[{"type":"text","content":"\n\n\n\n Vertex Announces Health Canada Acceptance of New Drug Submission for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-in-Class Triple Combination Treatment for Cystic Fibrosis\n \n\n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n \n\n\n\n\n\n Canada NewsWire\n \n\n\n\n\n\n TORONTO\n \n\n ,\n \n\n Sept. 26, 2024\n \n\n /CNW/ -\n \n Vertex Pharmaceuticals Incorporated\n \n (Nasdaq: VRTX) today announced 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\n \n F508del\n \n mutation or another responsive mutation in the\n \n cystic fibrosis transmembrane conductance regulator\n \n (\n \n CFTR\n \n ) gene.\n \n\n\n\n\n\n\n\n\n \"Vanzacaftor raises the bar set by TRIKAFTA\n \n ®\n \n by demonstrating comparable lung function improvement and additional improvements in CFTR function, as measured by sweat chloride in Phase 3 trials,\" said Michael Siauw, General Manager at Vertex Pharmaceuticals (\n \n Canada\n \n ) Incorporated. \"Health\n \n Canada's\n \n acceptance of the vanzacaftor submission for review brings us one step closer to providing a new treatment option, with potential for additional benefit, for eligible people living with CF.\"\n \n\n The NDS will be part of an aligned review with Canadian Health Technology Assessment (HTA) organizations,\n \n Canada's\n \n Drug Agency (CDA) and the Institut national d'excellence en santé et en services sociaux (INESSS) in Quebec.\n \n\n 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.\n \n\n\n About Cystic Fibrosis\n \n\n\n Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 92,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused ...