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Health Canada Grants Marketing Authorization 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
Health Canada Grants Marketing Authorization for KALYDECO® (ivacaftor) for Patients ...
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[{"type":"text","content":"\n \n \n \n Health Canada Grants Marketing Authorization 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\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 March 25, 2022\n \n \n /CNW/ -\n \n Vertex Pharmaceuticals (\n \n Canada\n \n ) Incorporated\n \n (NASDAQ: VRTX) today announced that Health Canada has granted Marketing Authorization for the expanded use of\n \n Pr\n \n KALYDECO® (ivacaftor) 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 \"KALYDECO was first approved in\n \n Canada\n \n in 2012 as the first medicine to treat the underlying cause of cystic fibrosis in patients with specific mutations,\" said Michael Siauw, General Manager, Vertex Pharmaceuticals (\n \n Canada\n \n ). \"Since then, it's been our goal to ensure that as many people with CF as possible are eligible for our treatments, and today's announcement means that approximately 25 young people with CF in Canada are now newly eligible for KALYDECO.\"\n \n \n Vertex will work closely with all provinces, territories and private payers to secure access for eligible patients as swiftly as possible.\n \n \n In Canada,\n \n Pr\n \n KALYDECO® is already approved for the treatment of people with CF ages 18 and older with the\n \n R117H\n \n mutation, and in people with CF ages 4 months and older weighing at least 5 kg who have one of the following mutations in the CFTR gene:\n \n G551D\n \n ,\n \n G1244E\n \n ,\n \n G1349D\n \n ,\n \n G178R\n \n ,\n \n G551S\n \n ,\n \n S1251N\n \n ,\n \n S1255P\n \n ,\n \n S549N\n \n or\n \n S549R\n \n .\n \n \n \n About Cystic Fibrosis\n \n \n \n Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 83,000 people globally. CF is a progressive, multi-organ disease...