The European Commission (EC) has approved Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).
The first orally-administered HIF-PH inhibitor available in the European Union, roxadustat increases haemoglobin (Hb) levels through a different mechanism of action compared to injectable erythropoiesis-stimulating agents (ESAs), which are typically co-administered with intravenous iron.
As a HIF-PH inhibitor, roxadustat activates the body's natural response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that allow management of anaemia with a reduced use of intravenous iron.
"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," added Jonathan Barratt, Ph.D., FRCP, Consultant nephrologist and the mayer professor of renal medicine at the University of Leicester, UK. "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."
The decision follows the European Medicines Agency's authorisation of roxadustat in June, based on results from a Phase III trial showing the drug achieved and maintained target Hb levels in patients with symptomatic anaemia of CKD.
The EC approval of roxadustat will prompt a milestone payment of $120 million by Astellas to FibroGen, in addition to royalties based on European sales.