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Vertex Announces New Drug Submission for Investigational Triple Combination Medicine for the Treatment of Cystic Fibrosis Has Been Accepted for Priority Review by Health Canada
Vertex Announces New Drug Submission for Investigational Triple Combination Medicine for ...
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[{"type":"text","content":"\n \n \n \n Vertex Announces New Drug Submission for Investigational Triple Combination Medicine for the Treatment of Cystic Fibrosis Has Been 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 BOSTON\n \n ,\n \n Dec. 28, 2020\n \n /CNW/ -\n \n Vertex Pharmaceuticals Incorporated\n \n (Nasdaq: VRTX) today announced its New Drug Submission for TRIKAFTA®, Vertex's investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in people ages 12 years and older.\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 anticipate this accelerated review process will enable access for patients as early as possible,\" said\n \n Carmen Bozic\n \n , M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex.\n \n \n With Priority Review, the conventional review timeline of 300 days is reduced to 180 days. The expected approval target by Health Canada is in the first half of 2021.\n \n \n \n About Cystic Fibrosis\n \n \n \n Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. 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 cystic fibrosis transmembrane conductance regulator (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 a genetic test, or genotyping test, lead to CF by creating non-working and/or too few CFTR proteins at the cell surface. ...