🇺🇸 VADADUSTAT in United States

FDA authorised VADADUSTAT on 27 March 2024 · 115 US adverse-event reports

Marketing authorisation

FDA — authorised 27 March 2024

  • Application: NDA215192
  • Marketing authorisation holder: AKEBIA
  • Local brand name: VAFSEO
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved VADADUSTAT, a new molecular entity, for marketing in the United States. The approval was granted to AKEBIA on 27 March 2024, following a standard expedited pathway. The application number for this approval is NDA215192.

Read official source →

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Death — 15 reports (13.04%)
  2. Cardiac Failure — 13 reports (11.3%)
  3. Haemoglobin Decreased — 13 reports (11.3%)
  4. Marasmus — 13 reports (11.3%)
  5. Drug Interaction — 12 reports (10.43%)
  6. Diarrhoea — 11 reports (9.57%)
  7. Off Label Use — 10 reports (8.7%)
  8. Pneumonia — 10 reports (8.7%)
  9. Cardiac Failure Congestive — 9 reports (7.83%)
  10. Nausea — 9 reports (7.83%)

Source database →

VADADUSTAT in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is VADADUSTAT approved in United States?

Yes. FDA authorised it on 27 March 2024.

Who is the marketing authorisation holder for VADADUSTAT in United States?

AKEBIA holds the US marketing authorisation.