Drug Development Pipeline
Elexacaftor (VX-445) + tezacaftor + ivacaftor
Restore CFTR Function
This program is testing elexacaftor (VX-445) in combination with tezacaftor and ivacaftor. Elexacaftor and tezacaftor are CFTR correctors. Correctors are drugs designed to fix the defective CFTR protein so that it can move to the proper place on the cell surface. Once CFTR protein reaches the cell surface, ivacaftor helps facilitate the opening of the chloride channel to allow chloride and sodium (salt) to move in and out of the cell.
Two phase 3 studies to test the safety and effectiveness of VX-445 in people with CF 12 years and older have been completed. In people with one copy of the F508del mutation and one minimal function mutation, VX-445 was associated with significant improvements in lung function, sweat chloride, pulmonary exacerbations and quality of life.
Vertex plans to submit a new drug application for VX-445 combined with tezacaftor/ivacaftor to the FDA in the third quarter of 2019.
This program is sponsored by Vertex Pharmaceuticals and partially funded by the Cystic Fibrosis Foundation. This program is being conducted within the Therapeutics Development Network (TDN).
Recent Elexacaftor (VX-445) + tezacaftor + ivacaftor Studies
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