CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - Vertex Pharmaceuticals (VRTX) announced the FDA has accepted New Drug Application for investigational once-daily vanzacaftor/tezacaftor/deutivacaftor triple combination therapy for people living with cystic fibrosis ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator gene responsive to the vanza triple. Vertex used a priority review voucher for this submission reducing the review time from 10 months to 6 months. The PDUFA target action date is January 2, 2025.
Vertex also received validation of its Marketing Authorization Application submission by the European Medicines Agency for patients ages 6 years and older.
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