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| Trade names | Vafseo |
| Other names | AKB-6548, PG-1016548 |
| AHFS/Drugs.com | Monograph |
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| CompTox Dashboard(EPA) | |
| ECHA InfoCard | 100.248.991 |
| Chemical and physical data | |
| Formula | C14H11ClN2O4 |
| Molar mass | 306.70 g·mol−1 |
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Vadadustat, sold under the brand nameVafseo, is amedication used for the treatment of symptomaticanemia associated withchronic kidney disease.[2][3] Vadadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor.[2]
The most common side effects includethromboembolic events (problems due to the formation of blood clots in the blood vessels),diarrhea, andhypertension (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][5][6]
In the EU, vadadustat isindicated for the treatment of symptomatic anemia associated with chronic kidney disease in adults on chronic maintenancedialysis.[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]
The USFood 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.[7] 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.[7] The same trials were used to evaluate the safety and efficacy of vadadustat.[7] INNO2VATE-1 and INNO2VATE-2 were both global, multi-center, randomized, active-controlled, non-inferiority, open-label trials.[7] 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.[7] Vadadustat was administered in increments of 150 mg up to 600 mg to achieve the hemoglobin (Hb) target.[7] After 52 weeks, participants continued study medication to assess long-term safety until a major adverse cardiovascular event (MACE) occurred.[7] Efficacy in each study was based on the difference in mean change of Hb from baseline to Weeks 24 to 36 of the trial.[7] An additional efficacy endpoint was the difference in the average change of Hb from baseline to Weeks 40 to 52.[7]
In February 2023, theCommittee for Medicinal Products for Human Use of theEuropean 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.[8] The applicant for this medicinal product is Akebia Europe Limited.[8] Vadadustat was approved for medical use in the European Union in April 2023.[3][4]
Vadadustat is in phase III clinical trials for the treatment ofanemia caused bychronic kidney disease.[9][10][11][12][13]
This article incorporates text from this source, which is in thepublic domain.