FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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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.