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[{"orgOrder":0,"company":"Napp Pharmaceuticals","sponsor":"Johnson & Johnson Innovative Medicine","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CHMP Issues Positive Opinion to Extend Invokana Indication to Reflect Improved Renal Outcomes in Diabetic Kidney and Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Napp Pharmaceuticals","sponsor":"Johnson & Johnson Innovative Medicine","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Napp Pharmaceuticals Announces European Commission Approval of Invokana\u00ae (canagliflozin) Label Update to Reflect Improved Renal Outcomes in Patients With Diabetic Kidney Disease and Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"}]

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            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.

            Lead Product(s): Canagliflozin

            Therapeutic Area: Nephrology Product Name: Invokana

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 02, 2020

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            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.

            Lead Product(s): Canagliflozin

            Therapeutic Area: Nephrology Product Name: Invokana

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 29, 2020

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