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Vertex Announces US FDA Approval for Label Extensions of ALYFTREK® and TRIKAFTA®, Expanding Availability of These Medicines to ~95% of All People With CF in the United States
-With this expansion, any variant that results in production of CFTR protein is now included in t...
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[{"type":"text","content":"Vertex Announces US FDA Approval for Label Extensions of ALYFTREK® and TRIKAFTA®, Expanding Availability of These Medicines to ~95% of All People With CF in the United States\n\n\n .bwalignc { text-align: center; list-style-position: inside }\n.bwlistcircle { list-style-type: circle }\n.bwlistdisc { list-style-type: disc }\n \n\n\n\n\n -With this expansion, any variant that results in production of CFTR protein is now included in the indication for ALYFTREK and TRIKAFTA, reinforcing the impact these medicines have, regardless of the location of the variant in the CFTR protein-\n \n\n\n\n -Approximately 800 more people with CF in the US are now eligible for a CFTR modulator for the first time-\n \n\n\n\n\n\n Vertex Pharmaceuticals Incorporated\n \n (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved expanded use of ALYFTREK\n \n ®\n \n (vanzacaftor/tezacaftor/ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (\n \n CFTR\n \n ) gene that is either responsive based on clinical and/or\n \n in vitro\n \n data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for TRIKAFTA\n \n ®\n \n (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older.\n \n\n This label expansion was supported by clinical and/or\n \n in vitro\n \n data from 564 variants demonstrating response to ALYFTREK and 521 variants demonstrating response to TRIKAFTA. As such, approximately 800 more people with a clinical diagnosis of CF in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time. This extension means approximately 95% of people with CF in the U.S. are now eligible for treatment with a CFTR modulator.\n \n\n “This groundbreaking approval represents more than 20 years of innovation in CF, including testing over 600 variants in our laboratory, demonstrating clinical effects in large clinical trials, and studying younger people with CF so they can be treated as early as possible,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “With this label expansion, any ...