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Vertex to file U.S. application for expanded use of Trikafta next quarter

September 10, 2020

Based on positive results from an open-label Phase 3 study, Vertex Pharmaceuticals (NASDAQ:VRTX) expects to file a U.S. supplemental marketing application next quarter seeking approval of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children ages 6 through 11 years old with cystic fibrosis (CF) who have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation.

The FDA approved the triple combo regimen in October 2019 for CF patients at least 12 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Global regulatory filings will follow.

https://seekingalpha.com/news/3612902-vertex-to-file-u-s-application-for-expanded-use-of-trikafta-next-quarter

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