A New Treatment Option for Chronic Kidney Disease: XOANACYL® (Ferric Citrate as Coordination Complex)
Cambridge, MA – April 3, 2025 – Akebia Therapeutics, Inc., a leading biopharmaceutical company dedicated to enhancing the lives of individuals affected by kidney disease, proudly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed a positive opinion, recommending the European Commission (EC) to authorize the use of XOANACYL® (Ferric Citrate as Coordination Complex) for the treatment of simultaneous high serum phosphorus and iron deficiency in adult patients with chronic kidney disease (CKD).
What is XOANACYL®?
XOANACYL® is a novel, orally administered iron replacement therapy that addresses the dual challenges of high serum phosphorus and iron deficiency in adult patients with CKD. By combining iron therapy with phosphate binding, XOANACYL® offers a convenient and effective solution for managing these common and debilitating complications of kidney disease.
Positive Opinion from the European Medicines Agency
The positive opinion from CHMP is based on the results of several clinical trials, which demonstrated the safety and efficacy of XOANACYL® in treating concomitant high serum phosphorus and iron deficiency in adult CKD patients. The trials showed that XOANACYL® significantly reduced serum phosphorus levels without increasing iron levels, while maintaining hemoglobin levels.
Impact on Individual Patients
For patients with CKD, the dual burden of high serum phosphorus and iron deficiency can lead to numerous health complications. XOANACYL® offers a potential solution by addressing both conditions with a single, convenient therapy. The approval of XOANACYL® in Europe is a significant step forward in providing these patients with an effective treatment option to help manage their kidney disease and improve their overall quality of life.
Global Implications
The positive opinion from the EMA marks an important milestone for Akebia Therapeutics and the kidney disease community. With the European Commission’s expected approval, XOANACYL® will become the first-in-class therapy for the treatment of concomitant high serum phosphorus and iron deficiency in adult patients with CKD. This approval is expected to pave the way for similar regulatory decisions in other regions, including the United States and Japan, providing hope and potential relief for millions of patients worldwide.
Conclusion
The positive opinion from the European Medicines Agency marks an exciting moment for the kidney disease community, as XOANACYL® (Ferric Citrate as Coordination Complex) moves one step closer to becoming an approved treatment for concomitant high serum phosphorus and iron deficiency in adult patients with chronic kidney disease. This breakthrough therapy offers a convenient and effective solution for managing these debilitating complications, improving the quality of life for countless individuals. As regulatory approvals continue to roll in, the global impact of XOANACYL® is poised to be substantial, offering hope and relief to millions of patients worldwide.
- Akebia Therapeutics announces positive opinion from CHMP of EMA for XOANACYL®
- XOANACYL® is a novel, orally administered iron replacement therapy for CKD patients with high serum phosphorus and iron deficiency
- Clinical trial results demonstrate safety and efficacy of XOANACYL®
- Expected European Commission approval will mark first-in-class therapy for CKD patients
- Global implications: US and Japan regulatory decisions expected
