Astellas Pharma Inc. and FibroGen, Inc. announced the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has been accepted by the European Medicines Agency (EMA) for regulatory review.
The MAA is supported by positive results from a pivotal Phase III program, which involved more than 9,000 patients worldwide. The MAA dossier includes the DOLOMITES study, the results of which will be disclosed later this year. Results from these studies support roxadustat as efficacious in increasing and maintaining target hemoglobin levels with reduced use of intravenous iron in adult patients with CKD anemia, both those who are dialysis dependent (DD) and those non-dialysis dependent (NDD). These data also support a favorable risk:benefit profile with cardiovascular (CV) and general safety of roxadustat reflective of the underlying conditions of the CKD population.