Vertex submits VX-445 NDA to FDA
Vertex announced the submission of a new drug application, or NDA, to the FDA for the VX-445, tezacaftor and ivacaftor triple combination regimen. The NDA includes a request for priority review, which, if granted, would shorten the FDA's review of the NDA to eight months from the time of submission, versus a standard review timeline of 12 months from submission. The submission is supported by previously disclosed positive results of two global Phase 3 studies: a 24-week Phase 3 study in people with one F508del mutation and one minimal function mutation and a 4-week Phase 3 study in people with two F508del mutations. Both Phase 3 studies showed statistically significant improvements in lung function, which was the primary endpoint, and in all key secondary endpoints. In these studies, the triple combination regimen was generally well tolerated.