Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
Vafseo is a medicine used to treat the symptoms of anaemia (low red blood cell counts) caused by chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly) in adult patients on dialysis (a technique for removing unwanted substances and excess fluid from the blood when the kidneys do not work well enough).
Vafseo contains the active substance vadadustat.
Active Substances (1)
Vadadustat
Documents (11)
Vafseo: EPAR - Medicine overview
May 31, 2023
OVERVIEW_DOCUMENT
Vafseo: EPAR - Risk-management-plan
May 31, 2023
RISK_MANAGEMENT_PLAN_SUMMARY
Vafseo: EPAR - Public assessment report
May 31, 2023
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of positive opinion for Vafseo
February 24, 2023
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Vafseo: EPAR - Product Information
May 31, 2023
DRUG_PRODUCT_INFORMATION
Vafseo: EPAR - Procedural steps taken and scientific information after authorisation
March 5, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Vafseo: EPAR - Procedural steps taken and scientific information after authorisation
March 27, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Vafseo: EPAR - Public assessment report
May 31, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Vafseo: EPAR - Procedural steps taken and scientific information after authorisation (archive)
March 5, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Vafseo
February 24, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Vafseo: EPAR - All authorised presentations
May 31, 2023
AUTHORISED_PRESENTATIONS
Overview Q&A (7)
Question
What are the risks associated with Vafseo?
Answer
For the full list of side effects and restrictions with Vafseo, see the package leaflet.
The most common side effects with Vafseo (which may affect more than 1 in 10 people) include thromboembolic events (problems due to the formation of blood clots in the blood vessels), diarrhoea and hypertension (high blood pressure).
Question
How is Vafseo used?
Answer
Vafseo can only be obtained with a prescription, and treatment should be started by a doctor experienced in the management of anaemia. It is available as tablets to be taken once a day.
For more information about using Vafseo, see the package leaflet or contact your doctor or pharmacist.
Question
How does Vafseo work?
Answer
Patients with chronic kidney disease may not produce enough erythropoietin, a hormone needed to stimulate the production of red blood cells. The active substance in Vafseo, vadadustat, acts on an enzyme called hypoxia-inducible factor prolyl hydroxylase (HIF-PH). This stimulates the natural response that normally occurs when oxygen levels are low, including the production of erythropoietin and red blood cells.
Question
What benefits of Vafseo have been shown in studies?
Answer
Two main studies involving nearly 4,000 patients with anaemia caused by chronic kidney disease who were on dialysis showed that Vafseo was as effective as darbepoetin alfa (another medicine for treating anaemia) at increasing blood levels of haemoglobin.
Question
Why is Vafseo authorised in the EU?
Answer
Vafseo was shown to be as effective as the comparator medicine darbepoetin alfa at treating anaemia in patients with chronic kidney disease who were on dialysis. With regard to safety, the risk of thromboembolic events in patients treated with Vafseo is addressed with warnings in the prescribing information. The European Medicines Agency therefore decided that Vafseo’s benefits are greater than its risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Vafseo?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vafseo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Vafseo are continuously monitored. Suspected side effects reported with Vafseo are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Vafseo
Answer
Vafseo received a marketing authorisation valid throughout the EU on 24 April 2023.
Further information on Vafseo can be found on the Agency’s website: ema.europa.eu/medicines/human/EPAR/vafseo
This overview was last updated in 04-2023.