According to the Zhitong Finance APP, Vertex Pharmaceuticals (VRTX.US) announced that the US FDA has accepted its new drug application (NDA) for once-daily Vanzacaftor/Tezacaftor/Ivacaftor triple combination therapy (Vanza triple combination therapy) to treat cystic fibrosis (CF) patients aged 6 and above who carry at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Patients with these mutations respond to Vanza triple combination therapy. Vertex has applied for priority review vouchers for this application, and the PDUFA target date is January 2, 2025.

In addition, the European Medicines Agency (EMA) has also completed the validation of Vertex's marketing authorization application (MAA) for this therapy for CF patients aged 6 and above in the European Union. The company has also submitted regulatory applications in Canada, Australia, Switzerland, and the United Kingdom.