Chemistry:Vadadustat

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Vadadustat, sold under the brand name Vafseo, is a medication used for the treatment of symptomatic anemia associated with chronic kidney disease.[1][2] Vadadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor.[1]

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).[2]

Vadadustat was approved for medical use in the European Union in April 2023,[2] and in the United States in March 2024.[1][3][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.[2]

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.[1]

History

The US Food and Drug Administration approved vadadustat based on evidence from two clinical trials, INNO2VATE-1 (NCT02865850) and INNO2VATE-2 (NCT02892149), in which 3,923 adults with anemia due to CKD who have been receiving dialysis for at least three months were equally randomized to receive either vadadustat or darbepoetin alfa.[5] The trials were conducted at 83 sites in one study and 275 sites in another study in a total of 18 countries in North America, South America, Europe, Africa, and Asia, of which 2,361 (60%) participants were from the United States.[5] The same trials were used to evaluate the safety and efficacy of vadadustat.[5] INNO2VATE-1 and INNO2VATE-2 were both global, multi-center, randomized, active-controlled, non-inferiority, open-label trials.[5] Participants in each trial were randomized equally to receive either vadadustat with a starting dose of 300 mg once daily or darbepoetin alfa administered subcutaneously or intravenously as per the prescribing information for 52 weeks to assess the efficacy endpoints.[5] Vadadustat was administered in increments of 150 mg up to 600 mg to achieve the hemoglobin (Hb) target.[5] After 52 weeks, participants continued study medication to assess long-term safety until a major adverse cardiovascular event (MACE) occurred.[5] Efficacy in each study was based on the difference in mean change of Hb from baseline to Weeks 24 to 36 of the trial.[5] An additional efficacy endpoint was the difference in the average change of Hb from baseline to Weeks 40 to 52.[5]

Society and culture

In February 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency 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.[6] The applicant for this medicinal product is Akebia Europe Limited.[6] Vadadustat was approved for medical use in the European Union in April 2023.[2][7]

Research

Vadadustat is in phase III clinical trials for the treatment of anemia caused by chronic kidney disease.[8][9][10][11][12]

References

  1. ↑ 1.0 1.1 1.2 1.3 Cite error: Invalid <ref> tag; no text was provided for refs named Vafseo FDA label
  2. ↑ 2.0 2.1 2.2 2.3 2.4 "Vafseo EPAR". 31 May 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/vafseo.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. ↑ "Novel Drug Approvals for 2024". 29 April 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024. 
  4. ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025. 
  5. ↑ 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 "Drug Trials Snapshots: Vafseo". 1 October 2024. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vafseo.  Public Domain This article incorporates text from this source, which is in the public domain.
  6. ↑ 6.0 6.1 "Vafseo: Pending EC decision". European Medicines Agency (EMA). 24 February 2023. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vafseo.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ↑ "Vafseo Product information". 25 April 2023. https://ec.europa.eu/health/documents/community-register/html/h1725.htm. 
  8. ↑ "Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease". Kidney International 90 (5): 1115–1122. November 2016. doi:10.1016/j.kint.2016.07.019. PMID 27650732. 
  9. ↑ "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. doi:10.1053/j.ajkd.2016.12.011. PMID 28242135. 
  10. ↑ "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. doi:10.1159/000464476. PMID 28343225. 
  11. ↑ "Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis". The New England Journal of Medicine 384 (17): 1601–1612. April 2021. doi:10.1056/NEJMoa2025956. PMID 33913638. 
  12. ↑ "Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD". The New England Journal of Medicine 384 (17): 1589–1600. April 2021. doi:10.1056/NEJMoa2035938. PMID 33913637. 
  • Clinical trial number NCT02865850 for "Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)" at ClinicalTrials.gov
  • Clinical trial number NCT02892149 for "Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)" at ClinicalTrials.gov



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