Submission for the treatment of anemia in adult patients with chronic kidney disease
TOKYO and San Francisco, May 21, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, “FibroGen”) today 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 3 program, which involved more than 9,000 patients worldwide.1-7 The MAA dossier includes the DOLOMITES study, the results of which will be disclosed later this year.8,9 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.1-6
“This acceptance marks a significant milestone for roxadustat, which we believe has the potential to offer an important new oral therapeutic option in the EU for the management of anemia in adults with chronic kidney disease,” said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. “Chronic kidney disease impacts one in eight people in Europe, of whom one in five are affected by anemia that is often untreated or not treated to target. We look forward to the review and assessment by EMA in the hope of bringing this innovative treatment to patients across the EU.”
“There is significant unmet medical need for patients with anemia of CKD, a serious and often life-threatening disease,” said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. “This submission and FibroGen’s recent submission of a New Drug Application in the U.S. are supported by positive results from the largest global phase 3 program in patients with CKD anemia. We look forward to working with Astellas during the EMA’s review of the MAA, and to the potential of roxadustat as a new therapeutic option for treating anemia in CKD patients on dialysis and not on dialysis across Europe.”
EMA’s acceptance of the roxadustat MAA for treatment of anemia in adult patients with CKD on dialysis and not on dialysis triggers a milestone payment of $130 million by Astellas to FibroGen.
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