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[{"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"},{"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"},{"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"},{"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"}]

Astellas Pharma

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New Roxadustat Data in Anemia of Chronic Kidney Disease to be Released by Astellas Pharma at the ASN Kidney Week 2020 Reimagined

Details:

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.

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Evrenzo

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: FibroGen

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 19, 2020

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Astellas Pharma

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Roxadustat Demonstrates Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Adult Patients with Chronic Kidney Disease

Details:

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.

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Evrenzo

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: FibroGen

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 08, 2020

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Astellas Pharma

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European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat

Details:

The MAA is supported by positive results from a pivotal Phase 3 program, which involved more than 9,000 patients worldwide.

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: ASP1517

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: FibroGen

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 21, 2020

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Astellas Pharma

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Astellas Submits sNDA for Approval of Evrenzo for the Treatment of CKD Associated Anemia in Non-Dialysis Dependent Patients in Japan

Details:

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.

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Evrenzo

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: FibroGen

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 30, 2020

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