Therapy Areas: Hereditary Disorders
Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis
31 May 2019 - - US-based biotechnology company Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis, the company said.

Final data has announced from a 24-week Phase 3 study in people with one F508del mutation and one minimal function mutation and from a 4-week Phase 3 study in people with two F508del mutations will form the basis of these submissions.

Vertex previously announced that both of these Phase 3 studies met their primary endpoints, and the company TODAY announced the final results of these studies, including results for key secondary endpoints and safety data.

In each study, treatment with the VX-445 triple combination regimen resulted in statistically significant improvements in all key secondary endpoints.

Data from the 24-week study in people with one F508delmutation and one minimal function mutation showed a mean absolute improvement in percent predicted forced expiratory volume in one second (ppFEV1) of 14.3 percentage points from baseline (p
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