AVEROA Receives Positive Opinion from the European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease (CKD)
- CHMP recommends approval for XOANACYL, an oral therapy for use in the following therapeutic areas: Iron deficiency, chronic renal failure and hyperphosphatemia
- Final European Commission decision expected by June 2025; UK regulatory submission foreseen via MHRA’s international recognition procedure
- AVEROA seeking strategic commercial partners to bring XOANACYL to market across Europe
Grenoble, France, April 2nd, 2025 - Averoa, a biopharmaceutical company bringing innovative therapeutic solutions to people with renal diseases, today announces a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for XOANACYL®, an oral therapy for chronic kidney disease (CKD). This milestone represents a key step toward a potential EU- approval.
XOANACYL (Ferric Citrate as Coordination Complex) is an oral therapy offering a dual mechanism of action for patients with CKD. This new treatment provides an effective source of ferric iron for addressing iron deficiency and plays a pivotal role in controlling phosphorus absorption. XOANACYL offers a comprehensive approach to improving patient outcomes in CKD.
XOANACYL was licensed from Akebia Therapeutics, Inc. (Akebia) in December 2022. Since then, Averoa has created an appropriate dossier, in particular by re-engineering the clinical package, to support the dual indication for the benefit of the European patients.
The marketing authorization application (MAA) was filed in March 2024 through the centralized European procedure, supported by three pivotal clinical studies performed by Akebia Therapeutics.
The positive opinion will now be reviewed by the European Committee (EC), which has the authority to approve medicines for European Union member states. The EC has approximately two months from the CHMP opinion to issue the final decision. Additionally, Averoa will submit a marketing authorization application to the Medicines and Healthcare products Regulatory Agency (MHRA), following the international recognition procedure (IRP) which has the authority to approve medicines for the UK market. A final MHRA decision is anticipated in the coming months.
Luc-André Granier, President and Medical Director at Averoa, said: “This positive CHMP opinion is a pivotal moment for Averoa. It validates our ability to successfully navigate European regulatory pathways and brings us one step closer to offering a novel therapy to CKD patients. We are now focused on securing the right commercial partners to bring XOANACYL to market and accelerate patient access.”
With EU approval expected in the coming months, Averoa is actively pursuing strategic commercial partnerships to support the launch and distribution of XOANACYL across Europe. The company is focused on collaboration models that can accelerate access to this innovative therapy and maximize its clinical and commercial impact.
