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Vanzacaftor/tezacaftor/deutivacaftor

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Vanzacaftor/tezacaftor/deutivacaftor
Combination of
VanzacaftorMedication
TezacaftorMedication
DeutivacaftorCFTR potentiator
Clinical data
Trade namesAlyftrek
License data
Routes of
administration
By mouth
ATC code
Legal status
Legal status
Identifiers
KEGG

Vanzacaftor/tezacaftor/deutivacaftor, sold under the brand name Alyftrek, is a fixed-dose combination medication used for the treatment of cystic fibrosis.[1] It is a combination of deutivacaftor, a CFTR potentiator; tezacaftor; and vanzacaftor, as the calcium salt, vanzacaftor calcium dihydrate.[1] It is taken by mouth.[1]

The combination was approved for medical use in the United States in December 2024.[2][3]

Medical uses

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The combination is indicated for the treatment of cystic fibrosis in people aged six years of age and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.[1][4]

Adverse affects

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The US Food and Drug Administration (FDA) prescription label for the combination contains a boxed warning about drug-induced liver injury and liver failure.[1]

History

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The FDA granted the application for vanzacaftor, tezacaftor, and deutivacaftor combination therapy orphan drug designation.[5]

Society and culture

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The combination was approved for medical use in the United States in December 2024.[2][6]

The combination is sold under the brand name Alyftrek.[1]

References

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  1. ^ a b c d e f g "Alyftrek- vanzacaftor, tezacaftor, and deutivacaftor tablet, film coated". DailyMed. 9 January 2025. Retrieved 25 January 2025.
  2. ^ a b "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 23 December 2024. Retrieved 24 December 2024.
  3. ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  4. ^ Bacalhau M, Camargo M, Magalhães-Ghiotto GA, Drumond S, Castelletti CH, Lopes-Pacheco M (March 2023). "Elexacaftor-Tezacaftor-Ivacaftor: A Life-Changing Triple Combination of CFTR Modulator Drugs for Cystic Fibrosis". Pharmaceuticals (Basel, Switzerland). 16 (3): 410. doi:10.3390/ph16030410. PMC 10053019. PMID 36986509.
  5. ^ "Alyftrek Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). Retrieved 24 December 2024.
  6. ^ "Vertex Announces US FDA Approval of Alyftrek, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis" (Press release). Vertex. 20 December 2024. Retrieved 24 December 2024 – via Business Wire.
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  • Clinical trial number NCT05033080 for "A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)" at ClinicalTrials.gov
  • Clinical trial number NCT05076149 for "A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation" at ClinicalTrials.gov