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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