---
schema_version: "secwatch.filing_event.v1"
accession: "0001517022-24-000031"
form_type: "8-K"
ticker: "AKBA"
cik: "0001517022"
company_name: "Akebia Therapeutics, Inc."
filed_at: "2024-03-28T23:59:59+00:00"
generated_at: "2026-06-04T06:05:17.991502+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Akebia Therapeutics receives FDA approval for Vafseo (vadadustat) for dialysis patients

## Summary
- FDA approved Vafseo for anemia due to CKD in adults on dialysis ≥3 months; boxed warning for thrombosis risks.
- Vafseo is a once-daily oral HIF-PH inhibitor; already approved in 37 countries.
- ~500,000 U.S. adult dialysis patients suffer from CKD anemia.
- Approval based on INNO2VATE Phase 3 program data published in NEJM 2021; plus Japan post-marketing data.
- Akebia plans U.S. launch with commercial team and CSL Vifor partnership; conference call March 28.

## SEC filing metadata
- accession: 0001517022-24-000031
- form_type: 8-K
- ticker: AKBA
- cik: 0001517022
- company_name: Akebia Therapeutics, Inc.
- filed_at: 2024-03-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1517022/000151702224000031/0001517022-24-000031-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1517022/000151702224000031/akba-20240327.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001517022-24-000031
- JSON: https://secwatch.observer/filing/0001517022-24-000031.json
- Plain text: https://secwatch.observer/filing/0001517022-24-000031.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.