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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
Vertex's Supplement to a New Drug Submission for KALYDECO® (ivacaftor) for Patients ...
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[{"type":"text","content":"\n \n \n \n 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\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 TORONTO\n \n ,\n \n Sept. 22, 2021\n \n /CNW/ -\n \n \n Vertex Pharmaceuticals Incorporated (\n \n Canada\n \n )\n \n \n (Nasdaq: VRTX) today announced its Supplement to a New Drug Submission for\n \n Pr\n \n KALYDECO\n \n ®\n \n (ivacaftor) has been accepted for priority review by Health Canada for the treatment of cystic fibrosis (CF) in patients from 4 months to 18 years of age and weighing at least 5 kg with the\n \n R117H\n \n mutation in the cystic fibrosis transmembrane conductance regulator (\n \n CFTR\n \n ) gene.\n \n \n \n \n \n \n \n \n \n \"We are pleased this submission has been accepted for Priority Review by Health Canada, and we hope that this will enable access for patients with the R117H mutation as soon as possible,\" said\n \n Duncan McKechnie\n \n , Senior Vice President, North America Commercial Operations, Vertex Pharmaceuticals. \"It's our goal to ensure as many people as possible with cystic fibrosis are able to access treatments for the underlying cause of their CF.\"\n \n \n \n About Cystic Fibrosis\n \n \n \n Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 80,000 people globally. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the\n \n CFTR\n \n gene. Children must inherit two defective\n \n CFTR\n \n genes — one from each parent — to have CF. While there are many different types of\n \n CFTR\n \n mutations that can cause the disease, the vast majority of all people with CF have at least one\n \n F508del\n \n mutation. These mutations, which can be determined by...