[{"orgOrder":0,"company":"Astellas Pharma","sponsor":"FibroGen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"FibroGen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Roxadustat Demonstrates Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Adult Patients with Chronic Kidney Disease","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"FibroGen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Roxadustat Data in Anemia of Chronic Kidney Disease to be Released by Astellas Pharma at the ASN Kidney Week 2020 Reimagined","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"FibroGen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astellas Submits sNDA for Approval of Evrenzo for the Treatment of CKD Associated Anemia in Non-Dialysis Dependent Patients in Japan","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"}]
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Abstracts include presentations of the Phase 3 DOLOMITES study and a Japanese Phase 3 CL-0310 study, with both studies evaluating roxadustat versus darbepoetin alfa as a treatment for patients with anemia of CKD not on dialysis.
The data showed non-inferiority of roxadustat to darbepoetin alfa in the correction of hemoglobin levels during the first 24 weeks of treatment, meeting the study's primary endpoint.
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.