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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of roxadustat (Evrenzo) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD), according to Astellas Pharma and FibroGen, the developers of the treatment.1
The CHMP based its opinion on a comprehensive package that included data for 9600 patients from a phase 3 program involving 8 multicenter and randomized studies. The trials were conducted at locations worldwide. The companies noted in a press release that the robust data demonstrate the efficacy of roxadustat in allowing patients with symptomatic anemia of CKD to reach and sustain target hemoglobin levels (10-12g/dL), regardless of prior erythropoietin stimulating agents (ESAs) received and dialysis status.
The European Commission now has 67 days from the date of the CHMP opinion to make a final decision on approval. An approval would make roxadustat commercially available in the European Union, as well as Iceland, Norway, Liechtenstein, and Northern Ireland.
"Anemia of CKD remains an under recognized and undertreated condition. Today's positive CHMP opinion marks a significant step in providing patients with a new and important treatment option for anemia associated with CKD, regardless of dialysis status," Bernhardt G. Zeiher, MD, chief medical officer, Astellas, stated in a press release. "We look forward to the review and assessment by the European Commission which, if positive, would make roxadustat the first [inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH)] approved in Europe to treat symptomatic anemia in adult patients with CKD."
The companies explained in the press release that the mechanism of action of roxadustat is not the same as ESAs’. Roxadustat is a HIF-PH inhibitor that triggers the body’s natural response to a reduction in the level of oxygen in the blood. “This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia with a reduced need for intravenous iron,” the companies explained.
"Anemia of CKD significantly affects the daily lives of those living with the condition," Mark Eisner, MD, MPH, chief medical officer, FibroGen, stated in the press release. "Roxadustat's novel mechanism of action and oral administration provide physicians with the opportunity to help redefine the management of symptomatic anemia of CKD."
In November 2020, roxadustat was approved in Japan for the treatment of adult patients with anemia of CKD who are not on dialysis.
In the United States, a new drug application (NDA) has been submitted to the FDA for the use of roxadustat for the treatment of anemia of CKD in both dialysis-dependent and non-dialysis-dependent patients; however, the FDA informed the companies that a meeting of the Cardiovascular and Renal Drug Advisory Committee will be held to review the NDA. The meeting is tentatively scheduled for July 15, 2021.2
1. Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease. Published online June 25, 2021. Accessed June 25, 2021. https://yhoo.it/3vUerZh
2. FibroGen Announces FDA Advisory Committee to Review Roxadustat New Drug Application Tentatively Scheduled for July 15, 2021. Published online April 6, 2021. Accessed June 25, 2021. https://bit.ly/3wWaYLm