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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 October 19, 2020
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.
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Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: ASP1517
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
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.
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Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: ASP1517
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
Details:
The MAA is supported by positive results from a pivotal Phase 3 program, which involved more than 9,000 patients worldwide.
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