European Agency accepts drug application for Roxadustat
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The European Medicines Agency has accepted a marketing authorization application from Astellas Pharmaceuticals for its hypoxia-inducible factor prolyl hydroxylase inhibitor roxadustat for the treatment of anemia in adult patients with chronic kidney disease.
The application included results from phase 3 of the Dolomites study that evaluated the efficacy and safety of roxadustat compared with darbepoetin alfa for the treatment of anemia in patients with stage 3 to 5 CKD. Roxadustat demonstrated non-inferiority to darbepoetin alfa to correct and maintain hemoglobin (Hb) levels, meeting the study’s primary endpoint, company officials said in a release.
Dolomites comprised 616 adult patients with anemia, 323 of whom received roxadustat and 293 received darbepoetin alfa. The response in correction of Hb levels was defined as achieving Hb greater than or equal to 11 g/dL and Hb change from baseline of great than or equal to 1g/dL.
The company said the overall incidence of treatment emergent adverse events was comparable between roxadustat and darbepoetin alfa (91.6% and 92.5%, respectively). A non-confirmatory analysis of adjudicated major adverse cardiovascular event (MACE)/MACE plus hospitalized unstable angina and hospitalized congestive heart failure (MACE+) outcomes showed hazard ratio point estimates of 0.81 and 0.90.
“The goal of treatment for anemia in CKD is to raise and stabilize hemoglobin levels, yet as many as half of CKD anemia patients have hemoglobin levels outside the recommended target values, often leaving them with debilitating symptoms that can make daily activities extremely challenging,” Jonathan Barratt, PhD, FRCP, consultant nephrologist and the Mayer Professor of Renal Medicine at the University of Leicester, United Kingdom, said. “The Dolomites study results demonstrate the ability of roxadustat to correct and maintain hemoglobin levels in people with CKD anemia not on dialysis for up to 2 years.”
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Barratt J. Abstract #MO001. Presented at: European Renal Association-European Dialysis and Transplantation Association annual conference, June 5-8, 2020 (virtual).
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