Vertex Pharmaceuticals Receives FDA Approval for Vanzacaftor Triple Combination for Cystic Fibrosis

Vertex Pharmaceuticals today announced that the FDA has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene. Alyftrek is a once-daily triple combination CFTR modulator therapy. In clinical trials, Alyftrek demonstrated superior improvements in lung function (ppFEV1) compared to Trikafta, with a mean absolute improvement of 3.2 percentage points. The approval of Alyftrek represents the next generation of CFTR modulator therapy, offering patients improved efficacy with a convenient once-daily dosing regimen.