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On August 19, Astellas Pharma and FibroGen announced that the European Commission (EC) has approved the listing of EVRENZO ™ (roxadustat, roxadustat) for the treatment of chronic kidney disease (CKD). ) Adult patients with related symptomatic anemia.

The global incidence of CKD is 1/10, and 1/5 of the patients suffer from anemia. CKD anemia is associated with reduced quality of life and progression to adverse cardiovascular disease and kidney disease outcomes.

Roxadustat is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved by the European Union. Compared with erythropoiesis stimulants (ESA), which are usually administered in combination with iron supplements, it raises hemoglobin (Hb) levels through a different mechanism of action. As a type of HIF-PHI, Roxastat can activate the body's natural response to the decrease of oxygen levels in the blood. This response involves the adjustment of multiple coordinated processes, allowing anemia to be managed by reducing the use of intravenous iron supplements.

The approval follows the positive opinions of the European Medicines Agency (EMA) Committee for Medicines for Human Use (CHMP) and is based on the results of a pivotal Phase 3 R&D project consisting of 8 multi-center and randomized studies. The project involves 9,600 patients worldwide. The results show that, regardless of the status of dialysis and previous ESA treatment, in patients with CKD symptomatic anemia, rosastat can effectively achieve and maintain the target Hb level (10-12 g/dL). The safety profile observed in the Roxastat development project is comparable to ESA and reflects the status of CKD patients in the study.

The EC's approval of roxadustat triggers Astellas to pay FibroGen a milestone payment of $120 million, and FibroGen will also receive royalties based on European net sales.

Anemia is an important early complication of CKD. As CKD worsens, it occurs more frequently and affects patients' daily life, self-care, and mobility. "HIF-PHI represents a major advancement in the treatment of CKD anemia," said Dr. Mark Eisner, Chief Medical Officer of Fabojin. "Roxastat provides an innovative breakthrough for patients suffering from this disease."

"We are very pleased that Evrenzo has been approved in the EU as the first oral HIF-PHI for the treatment of adult patients with CKD-related symptomatic anemia," said Dr. Steven Benner, President of Astellas Development. "Today's approval provides patients with A'first-in-class' treatment option. We look forward to providing roxastat to adult patients with CKD anemia in EU countries."