Long-Term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Adults and Adolescents with Cystic Fibrosis and at Least One F508del Allele: A Phase 3 Open-Label Extension Study

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Abstract Rationale Clinical and real-world studies show that elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is efficacious and safe in people with cystic fibrosis (CF) ≥12 years of age with at least one F508del allele. Objectives Given the potential for lifelong ELX/TEZ/IVA use, the long-term safety and efficacy of ELX/TEZ/IVA was assessed. Methods In this phase 3, open-label, single-arm extension study,...

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