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Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
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 October 02, 2020
Details:
Designation follows DAPA-CKD Phase III trial results in which Farxiga demonstrated unprecedented reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease.
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Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
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 August 30, 2020
Details:
Results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s Farxiga on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo in CKD patients.
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Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
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 August 27, 2020
Details:
Farxiga shows significant benefit across all primary and secondary endpoints in patients with chronic kidney disease with and without type-2 diabetes .
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Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
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 July 28, 2020
Details:
FARXIGA significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without type 2 diabetes.
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Lead Product(s): Sodium Zirconium Cyclosilicate
Therapeutic Area: Nephrology Product Name: Undisclosed
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 05, 2020
Details:
The 20 abstracts being presented, will include data on Lokelma (sodium zirconium cyclosilicate), roxadustat & Farxiga (dapagliflozin) across different stages of CKD and AstraZeneca’s ongoing commitment to exploring treatment options across the full continuum of renal care.
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Lead Product(s): Canagliflozin
Therapeutic Area: Nephrology Product Name: Undisclosed
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 29, 2020
Details:
Positive opinion is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which was stopped early based on a conclusive signal of efficacy in the prevention of the primary endpoint.
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Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Undisclosed
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 March 30, 2020
Details:
The decision was made following a routine assessment of efficacy and safety which showed Farxiga’s benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial.
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