Roxadustat was approved in
The sNDA for the use of roxadustat in NDD-CKD patients is supported by three studies in more than 500 Japanese patients, which establish the profile within this group of patients.1,2,3 The first, an open-label Phase 3 conversion study versus active comparator, darbepoetin alfa (genetical recombination) ('darbepoetin alfa'), met the primary efficacy endpoint of non-inferiority and continued to demonstrate maintenance of hemoglobin (Hb) levels over time.1 Roxadustat was well tolerated and the safety profile of roxadustat was comparable to that of darbepoetin alfa.1 The other two studies (one Phase 3 and one Phase 2) supports the safety and efficacy in patients naive to erythropoiesis-stimulating agents (ESAs).2,3
'The data demonstrates that roxadustat is effective in increasing and maintaining Hb levels within the target range in patients with anemia associated with CKD who are not on dialysis,' said Bernhardt G Zeiher, MD, Chief Medical Officer, Astellas. 'This submission is an important next step to bringing roxadustat to even more patients with this condition in
'We are excited to reach another important milestone for roxadustat and appreciate the joint team's commitment to addressing the significant unmet medical need of patients living with anemia associated with CKD,' said K Peony Yu, MD, Chief Medical Officer,
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.4 Worldwide, 1 in 10 people are living with CKD.5 In
Anemia is a common early complication of CKD,8 affecting approximately 20% of patients with CKD.9It results from the failing kidneys' diminished ability to produce erythropoietin, which stimulates red blood cell production from 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.10 Anemia associated with CKD increases the risk of adverse cardiovascular events, worsens renal outcomes and can negatively impact patients' quality of life.10,11,12
About Roxadustat
Roxadustat is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) that corrects anemia by a mechanism of action that is different from that of ESAs. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. The response activated by roxadustat involves the regulation of multiple, complementary processes to promote erythropoiesis and increase the blood's oxygen-carrying capacity. Roxadustat is approved and launched for the treatment of anemia associated with CKD in
About Astellas
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