Vadadustat Explained

Width:250
Tradename:Vafseo
Dailymedid:Vadadustat
Pregnancy Au:C
Atc Prefix:B03
Atc Suffix:XA08
Legal Au:S4
Legal Au Comment:[1]
Legal Us:Rx-only
Legal Us Comment:[2]
Legal Eu:Rx-only
Cas Number:1000025-07-9
Pubchem:23634441
Drugbank:DB12255
Chemspiderid:34958379
Unii:I60W9520VV
Kegg:D11078
Chembl:3646221
Pdb Ligand:A1Z
Synonyms:AKB-6548, PG-1016548
Iupac Name:2-([5-(3-Chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino)acetic acid
C:14
H:11
Cl:1
N:2
O:4
Smiles:Oc1cc(cnc1C(=O)NCC(=O)O)c2cccc(Cl)c2
Stdinchi:1S/C14H11ClN2O4/c15-10-3-1-2-8(4-10)9-5-11(18)13(16-6-9)14(21)17-7-12(19)20/h1-6,18H,7H2,(H,17,21)(H,19,20)
Stdinchikey:JGRXMPYUTJLTKT-UHFFFAOYSA-N

Vadadustat, sold under the brand name Vafseo, is a medication used for the treatment of symptomatic anemia associated with chronic kidney disease.[3] Vadadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor.

The most common side effects include thromboembolic events (problems due to the formation of blood clots in the blood vessels), diarrhea, and hypertension (high blood pressure).

Vadadustat was approved for medical use in the European Union in April 2023, and in the United States in March 2024.[4]

Medical uses

In the EU, vadadustat is indicated for the treatment of symptomatic anemia associated with chronic kidney disease in adults on chronic maintenance dialysis.

In the US, vadadustat is indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months.

Society and culture

Legal status

In February 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vafseo, intended for the treatment of symptomatic anemia in adults with chronic kidney disease who are on chronic dialysis. The applicant for this medicinal product is Akebia Europe Limited.[5] Vadadustat was approved for medical use in the European Union in April 2023.

Research

Vadadustat is in phase III clinical trials for the treatment of anemia caused by chronic kidney disease.[6] [7] [8] [9] [10]

Notes and References

  1. Web site: Vafseo APMDS . Therapeutic Goods Administration (TGA) . 17 October 2023 . 7 March 2024 . 2 January 2024 . https://web.archive.org/web/20240102020530/https://www.tga.gov.au/resources/auspmd/vafseo . live .
  2. Web site: Vafseo- vadadustat tablet, film coated . DailyMed . 27 March 2024 . 25 April 2024 . 25 April 2024 . https://web.archive.org/web/20240425054341/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac9da724-5a62-4ab6-a89c-376a25f6195b . live .
  3. Web site: Vafseo EPAR . European Medicines Agency . 31 May 2023 . 3 June 2023 . 3 June 2023 . https://web.archive.org/web/20230603060118/https://www.ema.europa.eu/en/medicines/human/EPAR/vafseo . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. Web site: Novel Drug Approvals for 2024 . U.S. Food and Drug Administration (FDA) . 29 April 2024 . 30 April 2024 . 30 April 2024 . https://web.archive.org/web/20240430031024/https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 . live .
  5. Web site: Vafseo: Pending EC decision . European Medicines Agency (EMA) . 24 February 2023 . 24 February 2023 . 25 February 2023 . https://web.archive.org/web/20230225075243/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vafseo . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH . Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease . Kidney International . 90 . 5 . 1115–1122 . November 2016 . 27650732 . 10.1016/j.kint.2016.07.019 . free .
  7. Gupta N, Wish JB . Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors: A Potential New Treatment for Anemia in Patients With CKD . American Journal of Kidney Diseases . 69 . 6 . 815–826 . June 2017 . 28242135 . 10.1053/j.ajkd.2016.12.011 . free .
  8. Martin ER, Smith MT, Maroni BJ, Zuraw QC, deGoma EM . Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease . American Journal of Nephrology . 45 . 5 . 380–388 . 2017 . 28343225 . 5452283 . 10.1159/000464476 .
  9. Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, Farag YM, Fishbane S, Hubert H, Jardine A, Khawaja Z, Koury MJ, Maroni BJ, Matsushita K, McCullough PA, Lewis EF, Luo W, Parfrey PS, Pergola P, Sarnak MJ, Spinowitz B, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Zwiech R, Chertow GM . Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis . The New England Journal of Medicine . 384 . 17 . 1601–1612 . April 2021 . 33913638 . 10.1056/NEJMoa2025956 . free .
  10. Chertow GM, Pergola PE, Farag YM, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU . Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD . The New England Journal of Medicine . 384 . 17 . 1589–1600 . April 2021 . 33913637 . 10.1056/NEJMoa2035938 . free .

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