EC approves Averoa’s Xoanacyl for CKD

French drug developer Averoa today announced that the European Commission (EC) has granted marketing authorization for Xoanacyl (ferric citrate coordination complex).

This follows the positive opinion issued in March by the committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), making Xoanacyl the only approved treatment for iron deficiency in patients with elevated serum phosphorus levels – a significant unmet need in the European CKD market.

Xoanacyl is a single oral therapy that addresses two common and co-occurring complications in adult patients with chronic kidney disease (CKD): iron deficiency and elevated serum phosphorus levels (hyperphosphatemia). Its dual mechanism of action allows for effective ferric iron supplementation while simultaneously reducing phosphorus absorption, helping to simplify treatment regimens, improve outcomes for patients with CKD, the Grenoble-based company noted.