Vadadustat

Last updated

Vadadustat
Vadadustat.svg
Clinical data
Trade names Vafseo
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
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB ligand
ECHA InfoCard 100.248.991 OOjs UI icon edit-ltr-progressive.svg
Chemical and physical data
Formula C14H11ClN2O4
Molar mass 306.70 g·mol−1
3D model (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. [3]

Contents

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]

Medical uses

Vadadustat is indicated for the treatment of symptomatic anemia associated with chronic kidney disease in adults on chronic maintenance dialysis. [3]

Society and culture

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]

Related Research Articles

<span class="mw-page-title-main">Kidney dialysis</span> Removal of nitrogenous waste and toxins from the body in place of or to augment the kidney

Kidney dialysis is the process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally. This is referred to as renal replacement therapy. The first successful dialysis was performed in 1943.

<span class="mw-page-title-main">Kidney failure</span> Disease where the kidneys fail to adequately filter waste products from the blood

Kidney failure, also known as end-stage kidney disease, is a medical condition in which the kidneys can no longer adequately filter waste products from the blood, functioning at less than 15% of normal levels. Kidney failure is classified as either acute kidney failure, which develops rapidly and may resolve; and chronic kidney failure, which develops slowly and can often be irreversible. Symptoms may include leg swelling, feeling tired, vomiting, loss of appetite, and confusion. Complications of acute and chronic failure include uremia, hyperkalaemia, and volume overload. Complications of chronic failure also include heart disease, high blood pressure, and anaemia.

<span class="mw-page-title-main">Enalapril</span> ACE inhibitor medication

Enalapril, sold under the brand name Vasotec among others, is an ACE inhibitor medication used to treat high blood pressure, diabetic kidney disease, and heart failure. For heart failure, it is generally used with a diuretic, such as furosemide. It is given by mouth or by injection into a vein. Onset of effects are typically within an hour when taken by mouth and last for up to a day.

<span class="mw-page-title-main">Chronic kidney disease</span> Medical condition

Chronic kidney disease (CKD) is a type of kidney disease in which a gradual loss of kidney function occurs over a period of months to years. Initially generally no symptoms are seen, but later symptoms may include leg swelling, feeling tired, vomiting, loss of appetite, and confusion. Complications can relate to hormonal dysfunction of the kidneys and include high blood pressure, bone disease, and anemia. Additionally CKD patients have markedly increased cardiovascular complications with increased risks of death and hospitalization.

Renal osteodystrophy is currently defined as an alteration of bone morphology in patients with chronic kidney disease (CKD). It is one measure of the skeletal component of the systemic disorder of chronic kidney disease-mineral and bone disorder (CKD-MBD). The term "renal osteodystrophy" was coined in 1943, 60 years after an association was identified between bone disease and kidney failure.

Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. Authorised by the European Medicines Agency on 28 August 2007, it stimulates erythropoiesis and is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy.

<span class="mw-page-title-main">Dapagliflozin</span> Diabetes medication

Dapagliflozin, sold under the brand names Farxiga (US) and Forxiga (EU) among others, is a medication used to treat type 2 diabetes. It is also used to treat adults with heart failure and chronic kidney disease. It reversibly inhibits sodium-glucose co-transporter 2 (SGLT-2) in the renal proximal convoluted tubule to reduce glucose reabsorption and increase urinary glucose excretion.

<span class="mw-page-title-main">Robert Provenzano</span> American physician

Robert Provenzano is an American nephrologist. He is also an Associate Clinical Professor of Medicine at Wayne State University School of Medicine.

Haemodialysis-associated amyloidosis is a form of systemic amyloidosis associated with chronic kidney failure. Amyloidosis is the accumulation of misfolded protein fibers in the body that can be associated with many chronic illnesses. Even though amyloidosis is common in chronic kidney disease (CKD) patients receiving chronic regular dialysis, it has also been reported in a patient with chronic kidney failure but who never received dialysis.

<span class="mw-page-title-main">HIF prolyl-hydroxylase inhibitor</span>

Not to be confused with Factor Inhibiting HIF Asparaginyl Hydroxylase Inhibitors

<span class="mw-page-title-main">Ruxolitinib</span> Medication

Ruxolitinib, sold under the brand name Jakafi among others, is a medication used for the treatment of intermediate or high-risk myelofibrosis, a type of myeloproliferative neoplasm that affects the bone marrow; polycythemia vera, when there has been an inadequate response to or intolerance of hydroxyurea; and steroid-refractory acute graft-versus-host disease. Ruxolitinib is a Janus kinase inhibitor. It was developed and marketed by Incyte Corp in the US under the brand name Jakafi, and by Novartis elsewhere in the world, under the brand name Jakavi.

Aluminium toxicity in people on dialysis is a problem for people on haemodialysis. Aluminium is often found in unfiltered water used to prepare dialysate. The dialysis process does not efficiently remove excess aluminium from the body, so it may build up over time. Aluminium is a potentially toxic metal, and aluminium poisoning may lead to mainly three disorders: aluminium-induced bone disease, microcytic anemia and neurological dysfunction (encephalopathy). Such conditions are more prominently observed in people with chronic kidney failure and especially in people on haemodialysis.

<span class="mw-page-title-main">Momelotinib</span> Medication

Momelotinib, sold under the brand name Ojjaara, is an anticancer medication used for the treatment of myelofibrosis. It is a Janus kinase inhibitor and it is taken by mouth.

Peginesatide, developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin.

Sucroferric oxyhydroxide, sold under the brand name Velphoro, is a non-calcium, iron-based phosphate binder used for the control of serum phosphorus levels in adults with chronic kidney disease (CKD) on haemodialysis (HD) or peritoneal dialysis (PD). It is used in form of chewable tablets.

<span class="mw-page-title-main">Finerenone</span> Chemical compound

Finerenone, sold under the brand name Kerendia and Firialta, is a medication used to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes. Finerenone is a non-steroidal mineralocorticoid receptor antagonist (MRA). It is taken orally.

<span class="mw-page-title-main">Roxadustat</span> Anti-anemia medication

Roxadustat, sold under the brand name Evrenzo, is an anti-anemia medication. Roxadustat is a HIF prolyl-hydroxylase inhibitor that increases endogenous production of erythropoietin and stimulates production of hemoglobin and red blood cells. It was investigated in clinical trials for the treatment of anemia caused by chronic kidney disease (CKD). It is taken by mouth. The drug was developed by FibroGen, in partnership with AstraZeneca.

<span class="mw-page-title-main">Daprodustat</span> Chemical compound

Daprodustat, sold under the brand name Duvroq among others, is a medication that is used for the treatment of anemia due to chronic kidney disease. It is a hypoxia-inducible factor prolyl hydroxylase inhibitor. It is taken by mouth.

<span class="mw-page-title-main">Vericiguat</span> Medication

Vericiguat, sold under the brand name Verquvo, is a medication used to reduce the risk of cardiovascular death and hospitalization in certain patients with heart failure after a recent acute decompensation event. It is taken by mouth. Vericiguat is a soluble guanylate cyclase (sGC) stimulator.

Peter Stenvinkel is a Swedish nephrologist and academic. He is a senior lecturer at Karolinska University Hospital and a professor of nephrology at Karolinska Institutet.

References

  1. 1 2 "Vafseo APMDS". Therapeutic Goods Administration (TGA). 17 October 2023. Archived from the original on 2 January 2024. Retrieved 7 March 2024.
  2. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215192Orig1s000ltr.pdf
  3. 1 2 3 4 5 6 "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. 1 2 "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. Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH (November 2016). "Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease". Kidney International. 90 (5): 1115–1122. doi: 10.1016/j.kint.2016.07.019 . PMID   27650732.
  6. Gupta N, Wish JB (June 2017). "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. doi: 10.1053/j.ajkd.2016.12.011 . PMID   28242135.
  7. Martin ER, Smith MT, Maroni BJ, Zuraw QC, deGoma EM (2017). "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. doi:10.1159/000464476. PMC   5452283 . PMID   28343225.
  8. Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, et al. (April 2021). "Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis". The New England Journal of Medicine. 384 (17): 1601–1612. doi: 10.1056/NEJMoa2025956 . PMID   33913638.
  9. Chertow GM, Pergola PE, Farag YM, Agarwal R, Arnold S, Bako G, et al. (April 2021). "Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD". The New England Journal of Medicine. 384 (17): 1589–1600. doi: 10.1056/NEJMoa2035938 . PMID   33913637.