The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for XOANACYL, an oral therapy developed by Averoa for the treatment of chronic kidney disease (CKD). The positive opinion represents a significant milestone toward potential European Union approval, with a final European Commission decision expected by June 2025.
XOANACYL (Ferric Citrate as Coordination Complex) offers a dual mechanism of action for CKD patients, providing an effective source of ferric iron to address iron deficiency while simultaneously controlling phosphorus absorption—two common complications in kidney disease.
Luc-André Granier, President and Medical Director at Averoa, stated: "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."
Regulatory Pathway and Development
Averoa licensed XOANACYL from Akebia Therapeutics in December 2022 and subsequently re-engineered the clinical package to support the dual indication for European patients. The marketing authorization application was submitted in March 2024 through the centralized European procedure, supported by three pivotal clinical studies originally conducted by Akebia Therapeutics.
Following the CHMP recommendation, the European Commission will review the application, with authority to approve medicines for European Union member states. This process typically takes approximately two months from the CHMP opinion.
Additionally, Averoa plans to submit a marketing authorization application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) following the international recognition procedure (IRP), with a final decision anticipated in the coming months.
Addressing a Significant Health Burden
Chronic Kidney Disease represents a major public health challenge affecting millions of people, with an estimated prevalence ranging from 3% to 17% in Europe. The progressive condition, characterized by gradual loss of kidney function, is among the ten leading causes of death in developed countries.
CKD commonly leads to two debilitating disorders: Iron Deficiency Anemia (IDA) and Mineral Bone Disorders (MBD). As the disease progresses, it can induce cardiovascular complications and potentially advance to end-stage kidney failure, which requires dialysis or kidney transplantation.
XOANACYL's dual mechanism addresses multiple aspects of CKD management, potentially offering a more comprehensive approach to improving patient outcomes compared to treatments targeting single symptoms.
Global Presence and Commercial Strategy
The therapy is already approved and commercialized in several regions worldwide under different brand names: as Auryxia in the United States by Akebia Therapeutics; as Riona in Japan by Japan Tobacco Inc.; and as Nephoxil in Taiwan by Panion & BF Biotech Inc. and in South Korea by Kyowa Kirin Korea Co. Ltd.
With EU approval on the horizon, Averoa is actively pursuing strategic commercial partnerships to support the launch and distribution of XOANACYL across Europe. The company aims to establish collaboration models that can accelerate patient access to this innovative therapy while maximizing its clinical and commercial impact.
About Averoa
Founded in December 2021, Averoa is a biopharmaceutical company focused on bringing innovative therapeutic solutions to people with renal diseases. The company's mission centers on building, advancing, and commercializing a strong pipeline of products to address significant unmet medical needs for patients with kidney or metabolic diseases.
The XOANACYL approval recommendation represents a significant achievement for the relatively young company, demonstrating its capability to navigate complex regulatory pathways and potentially bring important new treatment options to CKD patients across Europe.
