09:25 AM EDT, 07/02/2024 (MT Newswires) -- Vertex Pharmaceuticals ( VRTX ) said Tuesday that the US Food and Drug Administration has accepted its new-drug application for the combination therapy of vanzacaftor, tezacaftor, and deutivacaftor to treat people aged six years and older with cystic fibrosis.
The company said it used a priority review voucher for the submission, which reduces the review time to 6 months from 10 months. The Prescription Drug User Fee Act target action date has been set for Jan. 2.
Vertex has also submitted applications for marketing approval in Canada, Australia, Switzerland, and the UK.
Price: 470.00, Change: -1.25, Percent Change: -0.27