The company has requested Priority Review which, if granted, will shorten the review clock to eight months from the time of submission from 12 months.
Monday, July 22, 2019
Vertex files U.S. application for triplet cystic fibrosis regimen
Vertex Pharmaceuticals (NASDAQ:VRTX) has submitted a marketing application to the FDA seeking approval for VX-445 (elexacaftor, tezacaftor and ivacaftor) for the potential treatment of cystic fibrosis (CF) patients at least 12 years old with one F508del mutation and one minimal function mutation or two F508del mutations.
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