EU approves roxadustat for anaemia associated with chronic kidney disease

pharmafile | August 20, 2021 | News story | Medical Communications  

Europe has approved Evrenzo (roxadustat) for patients with anaemia associated with symptomatic chronic kidney disease.

Evrenzo is the first orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) to be made available in the European Union.

Evrenzo treats anaemia of CKD by increasing haemoglobin (Hb) levels through a different mechanism of action (MoA) compared with injectable erythropoiesis-stimulating agents (ESAs) which is the current standard of care and typically co-administered with intravenous (IV) iron.

Steven Benner, President of Development, Astellas, said: “We are very pleased Evrenzo has been approved as the first oral HIF-PH inhibitor to treat adult patients with symptomatic anaemia associated with CKD in the European Union.

“Today’s approval provides patients, regardless of dialysis status, with a first-in-class treatment option to address the multifaceted nature of this condition. We look forward to making roxadustat available to adult patients with anaemia of CKD in countries across the European Union.”

Jonathan Barratt, Consultant Nephrologist and the Mayer Professor of Renal Medicine at the University of Leicester, United Kingdom, said: “Anaemia is a significant and early complication of CKD that occurs with greater frequency and impact as CKD worsens, affecting patients’ day-to-day living, self-care and mobility.

“This approval represents a step forward in providing patients with an efficient and simple option to manage anaemia symptoms and maintain target haemoglobin levels to minimise the impact on their quality of life.”

CKD impacts one in 10 people globally, of whom one in five are affected by anaemia. Anaemia of CKD is often untreated or not treated to target, and is associated with reduced quality of life and progression to adverse cardiovascular (CV) and renal outcomes.

Lilly Subbotin

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