First-in-class therapy targets iron deficiency and phosphate imbalance in CKD, offering earlier intervention and simplified treatment for European patients.
The European Commission (EC) has formally approved
Xoanacyl’s approval addresses a significant unmet need in the treatment of these two common complications of CKD that affect more than 10 million people with CKD across Europe. Patients with CKD frequently experience iron deficiency anemia and phosphate dysregulation, conditions which contribute to cardiovascular disease, vascular calcification, and increased mortality. Current therapeutic strategies often fail to address both complications effectively and at early stages of the disease, according to a news release from Averoa (1). Xoanacyl’s single oral formulation offers a dual mechanism, supplementing ferric iron while concurrently reducing phosphorus absorption.
·Xoanacyl receives EU approval as the first dual-action oral therapy for CKD, treating both iron deficiency and hyperphosphatemia in one formulation.
·Ferric citrate-based Xoanacyl streamlines CKD treatment regimens by combining iron repletion and phosphate reduction in a single, oral therapeutic option.
·Averoa’s regulatory strategy showcases how restructured clinical data and localized dossiers can support EU drug approval for repurposed pharmaceutical products.
The marketing authorization is supported by data from three pivotal trials originally conducted by
Since acquiring the rights, Averoa has restructured the clinical dossier, aligning it with EU regulatory requirements and emphasizing the dual indication (1). The company focused on tailoring the submission to the specific needs of the European patient population, where treatment for phosphate imbalance is typically initiated only at advanced CKD stages, despite early detectability and its role in disease progression.
Oral iron therapies are often poorly tolerated or ineffective, and the under-treatment of phosphate dysregulation remains a gap in CKD management, according to Averoa (1). Xoanacyl is positioned to streamline the therapeutic approach, offering earlier and more comprehensive management of these interrelated complications.
“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,” said
The company has also submitted a marketing authorization application to the UK’s Medicines and Healthcare products Regulatory Agency under the International Recognition Procedure, signaling its intention to broaden access to the therapy beyond the EU (1).
CKD is characterized by the progressive loss of kidney function and is one of the ten leading causes of death in developed countries (1). In Europe, prevalence estimates range from 3% to 17%. CKD arises from a wide range of causes, including hypertension, diabetes, glomerulonephritis, polycystic kidney disease, and other hereditary or environmental factors. The condition often leads to complications, such as iron deficiency anemia and mineral and bone disorders, both of which contribute to increased fibroblast growth factor 23 (FGF23) and cardiovascular risk.
Without effective early treatment, CKD can progress to end-stage kidney failure, requiring dialysis or transplantation. The dual therapeutic action of Xoanacyl offers a more integrated pharmacological approach to slowing this progression by addressing two key metabolic imbalances concurrently.
Xoanacyl has already been commercialized under different brand names in other regions, including
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