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Details:
Evrenzo (roxadustat) is an oral medication, comprised of HIF-PH inhibitors that promote erythropoiesis, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2023
Details:
Evrenzo (roxadustat) is an oral medication, comprising HIF-PH inhibitors that promote erythropoiesis, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2023
Details:
Evrenzo (roxadustat), a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, promotes coordinated erythropoiesis through increasing endogenous erythropoietin, improving iron availability, and reducing hepcidin.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: NovaQuest Capital Management
Deal Size: $50.0 million Upfront Cash: $50.0 million
Deal Type: Financing November 07, 2022
Details:
Recent endorsement of Evrenzo (roxadustat) by the National Institute for Health and Care Excellence (NICE) could be a catalyst for further use as alternative to erythropoietin stimulating agents (ESAs).
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
Evrenzo (roxadustat) was non-inferior to ESA for risk of a major adverse cardiovascular event, and major adverse cardiovascular event plus congestive heart failure or unstable angina requiring hospitalization with a consistent finding for all-cause mortality.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2022
Details:
Roxadustat increases hemoglobin (Hb) levels through a different mechanism of action compared to injectable erythropoiesis-stimulating agents (ESAs) which are typically co-administered with intravenous iron.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2021
Details:
Roxadustat is the first orally administered HIF-PH inhibitor available in the European Union. Roxadustat increases hemoglobin (Hb) levels through a different mechanism of action compared to injectable erythropoiesis-stimulating agents (ESAs).
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2021
Details:
The safety and efficacy of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, have been demonstrated in the Phase III programme including more than 8,000 patients and published in five peer-reviewed journal articles.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2021
Details:
The safety and efficacy of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, have been demonstrated in the Phase III programme including more than 8,000 patients and published in five peer-reviewed journal articles.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2021
Details:
The results of this program support roxadustat as efficacious in achieving and maintaining target Hb levels (10-12g/dL) in patients with symptomatic anemia of CKD regardless of dialysis status and irrespective of prior ESA treatment.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2021
Details:
As a HIF-PH inhibitor, roxadustat activates the body's natural response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia with a reduced need for intravenous iron.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2021
Details:
US FDA has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anaemia of chronic kidney disease (CKD).
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2020
Details:
The MHLW approval of EVRENZO marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched for use in adult patients with anemia of CKD on dialysis last year.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 27, 2020
Details:
Two analyses of pooled data from the roxadustat global Phase 3 development program to be presented during the American Society of Nephrology Kidney Week 2020 Reimagined.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: ASP1517
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
For roxadustat, more than 40 abstracts present safety and efficacy outcomes in anaemia of chronic kidney disease.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 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.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 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.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
Details:
Roxadustat demonstrates non-inferiority to darbepoetin alfa in achievement of Hb correction in DOLOMITES Phase 3 study of anemia in non-dialysis dependent patients with chronic kidney disease.
Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: Evrenzo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
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 IIIProduct 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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