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
'There is significant unmet medical need for patients with anemia of CKD, a serious and often life-threatening disease,' said
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
About CKD and Anemia
CKD is a progressive loss of kidney function caused by damage to the kidneys resulting from conditions such as hypertension, diabetes or immune-regulated inflammatory conditions.10 Worldwide 1 in 10 people are living with CKD.11 In Europe 1 in 8 people are living with CKD,11 of whom 1 in 5 are affected by anemia, this rises to 1 in 2 in people with the most severe CKD (CKD stage 5).12 CKD is predicted to become the fifth most common cause of premature death globally by 2040.13 It is a critical worldwide healthcare issue that represents a large and growing unmet medical need.
Anemia is a common complication of CKD,14 resulting from the failing kidneys' diminished ability to produce erythropoietin, which stimulates red blood cell production in the bone marrow. It is associated with significant morbidity and mortality in dialysis and non-dialysis populations, increasing in both prevalence and severity as kidney disease worsens.15 Anemia associated with CKD increases the risk of adverse cardiovascular events, worsens renal outcomes and can negatively impact patients' quality of life.16-18
About Roxadustat
Roxadustat is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), which increases hemoglobin levels with a mechanism of action that is different from that of erythropoiesis-stimulating agents. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. This response involves the regulation of multiple, complementary processes to promote erythropoiesis and to increase the blood's oxygen-carrying capacity.
Roxadustat is approved and launched for the treatment of anemia associated with CKD in
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Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement or medical advice.
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