Vadadustat

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Vadadustat
Clinical data
Trade namesVafseo
Other namesAKB-6548, PG-1016548
License data
Pregnancy
category
ATC code
Legal status
Legal status
Identifiers
  • 2-([5-(3-Chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino)acetic acid
JSmol)
  • Oc1cc(cnc1C(=O)NCC(=O)O)c2cccc(Cl)c2
  • InChI=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)
  • Key: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.[2][3] Vadadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor.[2]

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).[3]

Vadadustat was approved for medical use in the European Union in April 2023,[3] and in the United States in March 2024.[2]

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.[3]

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.[2]

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.[4] The applicant for this medicinal product is Akebia Europe Limited.[4] Vadadustat was approved for medical use in the European Union in April 2023.[3]

Research

Vadadustat is in phase III clinical trials for the treatment of anemia caused by chronic kidney disease.[5][6][7][8][9]

References

  1. ^ a b "Vafseo APMDS". Therapeutic Goods Administration (TGA). 17 October 2023. Archived from the original on 2 January 2024. Retrieved 7 March 2024.
  2. ^ a b c d e "Vafseo- vadadustat tablet, film coated". DailyMed. 27 March 2024. Retrieved 25 April 2024.
  3. ^ a b c d e f "Vafseo EPAR". European Medicines Agency. 31 May 2023. Archived from the original on 3 June 2023. Retrieved 3 June 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. ^ a b "Vafseo: Pending EC decision". European Medicines Agency (EMA). 24 February 2023. Archived from the original on 25 February 2023. Retrieved 24 February 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. PMID 27650732
    .
  6. PMID 28242135
    .
  7. PMID 28343225
    .
  8. PMID 33913638.{{cite journal}}: CS1 maint: overridden setting (link
    )
  9. PMID 33913637.{{cite journal}}: CS1 maint: overridden setting (link
    )


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