The U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), Vertex Pharmaceuticals' new once-daily triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator. This approval is for patients aged 6 years and older with at least one F508del mutation or another responsive mutation in the CFTR gene.
ALYFTREK is Vertex's fifth CFTR modulator to receive FDA approval, reinforcing the company's leadership in cystic fibrosis treatment. Clinical trials demonstrated ALYFTREK's non-inferiority to TRIKAFTA on lung function (ppFEV1) and a further decrease in sweat chloride, indicating improved CFTR function.
This new therapy offers a potentially transformative option for approximately 150 people with CF in the U.S. who have one of 31 specific mutations and are now eligible for a CFTR modulator for the first time. The once-daily dosing regimen also provides a convenience benefit for patients.
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