FDA Approves Alyftrek, Once-Daily CFTR Modulator for Cystic Fibrosis - Pharmacy Times

The FDA approved vanzacaftor/tezacaftor/deutivacaftor (Alyftrek) for cystic fibrosis in patients 6+ with at least 1 F508del mutation or a responsive mutation. Alyftrek, a once-daily CFTR modulator, met primary and secondary endpoints in phase 3 trials, showing non-inferiority to Trikafta in ppFEV1 and superiority in reducing sweat chloride levels.