Vanzacaftor, Tezacaftor, and Deutivacaftor (Alyftrek) for Cystic Fibrosis
March 17, 2025 (Issue: 1724)
The FDA has approved Alyftrek (Vertex), an oral
fixed-dose combination of the cystic fibrosis
transmembrane conductance regulator (CFTR)
modulators vanzacaftor, tezacaftor, and deutivacaftor,
for once-daily treatment of cystic fibrosis (CF)...more
- Elexacaftor/tezacaftor/ivacaftor (Trikafta) for cystic fibrosis. Med Lett Drugs Ther 2020; 62:5.
- T Ong and BW Ramsey. Cystic fibrosis: a review. JAMA 2023; 329:1859. doi:10.1001/jama.2023.8120
- H Grasemann and F Ratjen. Cystic fibrosis. N Engl J Med 2023; 389:1693. doi:10.1056/nejmra2216474
- PG Middleton et al. Elexacaftor-tezacaftor-ivacaftor for cystic fibrosis with a single Phe508del allele. N Engl J Med 2019; 381:1809. doi:10.1056/nejmoa1908639
- HGM Heijerman et al. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet 2019; 394:1940. doi:10.1016/s0140-6736(19)32597-8
- Vertex Pharmaceuticals Press Release. Vertex announces US FDA approval of Alyftrek, a once-daily next-in-class CFTR modulator for the treatment of cystic fibrosis. December 20, 2024. Available at: https://bit.ly/4hS3H6J. Accessed February 27, 2025.
- C Keating et al. Vanzacaftor-tezacaftor-deutivacaftor versus elexacaftor-tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years and older (SKYLINE trials VX20-121-102 and VX20-121-103): results from two randomised, active-controlled, phase 3 trials. Lancet Respir Med 2024 Dec 20 (epub). doi:10.1016/s2213-2600(24)00411-9
- JE Hoppe et al. Vanzacaftor-tezacaftor-deutivacaftor for children aged 6-11 years with cystic fibrosis (RIDGELINE trial VX21-121-105): an analysis from a single-arm, phase 3 trial. Lancet Respir Med 2024 Dec 20 (epub). doi:10.1016/s2213-2600(24)00407-7
- B Collins et al. Drug exposure to infants born to mothers taking elexacaftor, tezacaftor, and ivacaftor. J Cyst Fibros 2022; 21:725. doi:10.1016/j.jcf.2021.12.004
- Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Vanzacaftor, tezacaftor and deutivacaftor. [Updated 2025 Jan 15]. Available at: https://bit.ly/4khjeOO. Accessed February 27, 2025.
- EF Nash et al. Outcomes of pregnancy in women with cystic fibrosis (CF) taking CFTR modulators – an international survey. J Cyst Fibros 2020; 19:521. doi:10.1016/j.jcf.2020.02.018
- Inhibitors and inducers of CYP enzymes, P-glycoprotein, and other transporters. Med Lett Drugs Ther 2023 January 25 (epub). Available at: www.medicalletter.org/downloads/CYP_PGP_Tables.pdf.
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