Vertex's triple combo granted priority review

The US Food and Drug Administration (FDA) has accepted Vertex Pharmaceuticals’ (Nasdaq: VRTX) New Drug Application (NDA) for a triple therapy combination in cystic fibrosis (CF), and granted priority review to the submission.

Vertex’ regimen comprises of elexacaftor – a drug that till now has been referred to as VX-445 – along with tezacaftor and ivacaftor. The FDA has set a Prescription Drug User Fee Act target action date of March 19, 2020.

The application is supported by positive results from two global Phase III studies in people with CF aged 12 years and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations.