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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Dapagliflozin

            Therapeutic Area: Nephrology Product Name: Farxiga

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 30, 2021

            Details:

            Approval is based on DAPA-CKD Phase III trial in which FARXIGA demonstrated unprecedented reduction in the risk of the composite of worsening of renal function, end stage kidney disease and cardiovascular or renal death.

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            Lead Product(s): Sodium Zirconium Cyclosilicate

            Therapeutic Area: Nephrology Product Name: Lokelma

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 24, 2020

            Details:

            The approval by the NMPA was based on data from the Phase IIIb DIALIZE trial. The trial showed sustained potassium control pre-dialysis for more patients receiving Lokelma, compared with placebo.

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            Lead Product(s): Canagliflozin

            Therapeutic Area: Nephrology Product Name: Invokana

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 02, 2020

            Details:

            The European Commission approval 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 the achievement of a pre-specified efficacy criterion.