The European Commission (EC) has granted marketing authorisation for Averoa’s oral therapy Xoanacyl for chronic kidney disease (CKD), a condition characterised by the progressive loss of kidney function.
This decision follows the European Medicines Agency’s Committee for Medicinal Products for Human Use’s positive opinion in March 2025, marking Xoanacyl as the sole approved therapy for iron deficiency in CKD subjects with high serum phosphorus levels.
Go deeper with GlobalData
Xoanacyl, with its active ingredient ferric citrate as a coordination complex, targets iron deficiency and hyperphosphatemia – two prevalent complications in adult CKD subjects – by supplementing ferric iron and decreasing the absorption of phosphorus.
Averoa licensed the oral therapy from Akebia Therapeutics in December 2022, aiming to make it accessible throughout Europe.
Akebia has provided Averoa with an exclusive development and commercialisation licence for the therapy in the UK, the European Economic Area, Turkey, Switzerland, Israel and select nations in Eastern Europe.
The European authorisation is backed by data from three pivotal trials carried out by Akebia, showing the therapy’s efficacy in raising iron levels and lowering serum phosphorus in CKD patients.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataSince obtaining the rights, Averoa has revamped the clinical package and created a comprehensive European dossier to back the dual indication, focusing on the needs of patients and achieving approval throughout the European Union (EU).
Under the international recognition procedure, Averoa has also applied for marketing authorisation with the UK’s Medicines and Healthcare products Regulatory Agency.
Averoa medical director and president Luc-André Granier stated: “This approval represents a major strategic milestone for our company, opening the door to one of Europe’s most important healthcare markets, where tens of millions of people are living with chronic kidney disease.
“It underscores Averoa’s ability to translate scientific excellence into real-world patient impact. We are deeply grateful to all our partners who made this milestone possible, and we are proud to bring this novel therapy to CKD patients across Europe.”
