Astellas Pharma and Fibrogen announced on 25 June 2021 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the approval of Evrenzo (roxadustat) for symptomatic anemia associated with chronic kidney disease (CKD). The CHMP’s positive opinions are likely to shed more light on Evrenzo’s ability to activate the body’s natural response to reduced levels of oxygen in the blood, says GlobalData, a leading data and analytics company.

Kajal Jaddoo, Pharma Analyst at GlobalData, comments: “This is significant as it can lead to the correction of anemia with a reduced need for intravenous iron therapies. If approved, Evrenzo will be the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to become available in Europe for symptomatic anemia in adults with CKD. Key opinion leaders (KOLs) have stated that HIF-PHIs would likely replace erythropoiesis-stimulating agents (ESAs) when they are used.”

For CKD anemia, the current standard-of-care ESAs have historically been associated with increased risks of cardiovascular safety events, prompting the FDA numerous times to strengthen the safety information on ESAs. Evrenzo’s new mechanism of action and oral formulation may potentially help physicians redefine the management of symptomatic CKD anemia.

Ms Jaddoo concludes: “KOLs have emphasized that HIF-PHIs should preferably be used in patients who are young, have minimal cardiovascular risk, no diabetes, no high blood pressure, and those with early-stage CKD anemia. Also, until further clinical trial data solidify superior or non-inferior safety of HIF-PHIs in comparison to marketed therapies, physicians will not substantially change their prescribing patterns.

“The high price compared to ESAs may prove a problem, restricting reimbursement and affecting uptake in a market with widespread domestic ESA biosimilar uptake.”