Vertex was developing elexacaftor (VX-445) and VX-659 in parallel trials for the treatment of Cystic fibrosis caused by the F508del genetic mutation. Both drugs were used in combination with tezacaftor/ivacaftor. In May 2019 Vertex announced it would cease development of VX-659 and move forward with a combination of tezacaftor/ivacaftor/elexacaftor. Elexacaftor was chosen because it demonstrated more favorable safety and tolerability profile and could be co-administered with hormonal contraceptives. Researchers estimate the combination of elexacaftor with tezacaftor/ivacaftor could treat the underlying cause of CF in 90% of cystic fibrosis patients. Ivacaftor is estimated to treat 40% of patients and the combination of tezacaftor/ivacaftor to treat half of CF patients. Vertex plans to submit an NDA for tezacaftor/ivacaftor/elexacaftor in 3Q19 and a MAA in 4Q19.
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