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Vertex Announces European Commission Approval of ALYFTREK®, a New Once-Daily CFTR Modulator for the Treatment of Cystic Fibrosis
- ALYFTREK ® (deutivacaftor/tezacaftor/vanzacaftor) approved in the EU for people with C...
About this update from Vortex Energy Corp.
[{"type":"text","content":"Vertex Announces European Commission Approval of ALYFTREK®, a New Once-Daily CFTR Modulator for the Treatment of Cystic Fibrosis\n\n\n .bwalignc { text-align: center; list-style-position: inside }\n \n\n\n\n\n - ALYFTREK\n \n ®\n \n (deutivacaftor/tezacaftor/vanzacaftor) approved in the EU for people with CF 6 years and older with at least one non-class I mutation in the CFTR gene, making it the broadest label for this medicine in the world -\n \n\n\n\n - In head-to-head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV\n \n 1\n \n and superior compared to KAFTRIO\n \n ®\n \n (ivacaftor/tezacaftor/elexacaftor) at reducing sweat chloride, demonstrating greater improvement in CFTR function -\n \n\n\n\n - Approximately 31,000 people with CF in the EU are now eligible for this new highly effective modulator therapy -\n \n\n\n\n\n\n Vertex Pharmaceuticals\n \n (Nasdaq: VRTX) today announced that the European Commission has granted approval for ALYFTREK\n \n\n ®\n \n\n\n\n (deutivacaftor/tezacaftor/vanzacaftor)\n \n\n for the treatment of people with cystic fibrosis (CF) ages 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (\n \n CFTR\n \n ) gene.\n \n\n “Thousands of people with CF across the EU may now benefit from this new, once-daily medicine, which has demonstrated further improvement in CFTR protein function versus KAFTRIO,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “With this approval, we are one step closer to our ultimate goal of restoring normal levels of CFTR function in people living with CF.”\n \n\n In two head-to-head pivotal clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior to KAFTRIO\n \n ®\n \n (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor on ppFEV\n \n 1\n \n and superior at reducing sweat chloride, demonstrating greater improvement in CFTR function.\n \n\n “CF care has been transformed by the advent of highly effective CFTR modulators, and I am very pleased that we now have a new treatment option to even better address this multi-systemic disease,” said Professor Marcus A. Mall, M.D., Professor and Chair of the Department of Pediatric Respiratory Medicine, Immunology and Cr...