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[{"company":"Boehringer Ingelheim GmbH","sponsor":"Eli Lilly","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA grants Fast Track designation to Jardiance\u00ae\r\n","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Boehringer Ingelheim GmbH"},{"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer\u2019s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients with Chronic Kidney Disease and T2D","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Data from Phase III FIDELIO-DKD Study Presented at the American Society of Nephrology (ASN)\u2019s Kidney Week 2020","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"company":"Boehringer Ingelheim GmbH","sponsor":"Eli Lilly","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Boehringer Ingelheim's and Lilly's New Jardiance\u00ae Findings Showed Improved Cardio-Renal Outcomes in Adults with Heart Failure with Reduced Ejection Fraction Regardless of CKD status","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Boehringer Ingelheim GmbH"},{"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer Presents FIDELIO-DKD Phase III Study Cardiovascular Subgroup Analysis of Patients With Chronic Kidney Disease and Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Grants Priority Review to New Drug Application for Finerenone to Treat Patients with Chronic Kidney Disease and Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer\u2019s Finerenone Meets Primary Endpoint in Phase III FIGARO-DKD CV Outcomes Study in Chronic Kidney Disease and T2D Patients","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer Submits Application in the EU for an Extension of the Indication of Finerenone to Include Early Stages of Chronic Kidney Disease Associated With Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"company":"Boehringer Ingelheim GmbH","sponsor":"Eli Lilly","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Jardiance\u00ae (empagliflozin) Phase III EMPA-KIDNEY trial Will Stop Early Due to Clear Positive Efficacy in People With Chronic Kidney Disease","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Boehringer Ingelheim GmbH"}]

Bayer AG

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Bayer Submits Application in the EU for an Extension of the Indication of Finerenone to Include Early Stages of Chronic Kidney Disease Associated With Type 2 Diabetes

Details:

The submission is based on positive data from the FIGARO-DKD study, which demonstrated that Kerendia (finerenone) significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D.

Lead Product(s): Finerenone

Therapeutic Area: Nephrology Product Name: Kerendia

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 16, 2022

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Boehringer Ingelheim GmbH

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Jardiance® (empagliflozin) Phase III EMPA-KIDNEY trial Will Stop Early Due to Clear Positive Efficacy in People With Chronic Kidney Disease

Details:

Jardiance (empagliflozin), is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several countries.

Lead Product(s): Empagliflozin

Therapeutic Area: Nephrology Product Name: Jardiance

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Eli Lilly

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 16, 2022

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Bayer AG

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Bayer’s Finerenone Meets Primary Endpoint in Phase III FIGARO-DKD CV Outcomes Study in Chronic Kidney Disease and T2D Patients

Details:

Finerenone significantly reduced the composite primary endpoint of cardiovascular death and non-fatal cardiovascular events versus placebo when added to standard of care.

Lead Product(s): Finerenone

Therapeutic Area: Nephrology Product Name: BAY94-8862

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 10, 2021

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Bayer AG

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U.S. FDA Grants Priority Review to New Drug Application for Finerenone to Treat Patients with Chronic Kidney Disease and Type 2 Diabetes

Details:

The NDA was based on Phase III FIDELIO-DKD trial data. Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist that showed renal and cardiovascular benefits in patients with CKD and T2D in the Phase III FIDELIO-DKD study.

Lead Product(s): Finerenone

Therapeutic Area: Nephrology Product Name: BAY 94-8862

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 January 12, 2021

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Bayer AG

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Bayer Presents FIDELIO-DKD Phase III Study Cardiovascular Subgroup Analysis of Patients With Chronic Kidney Disease and Type 2 Diabetes

Details:

The FIDELIO-DKD data were presented in October at the American Society of Nephrology’s (ASN) Kidney Week 2020, and simultaneously published in the New England Journal of Medicine. Based on these data, Bayer submitted finerenone for marketing authorization in the US and the EU.

Lead Product(s): Finerenone

Therapeutic Area: Nephrology Product Name: BAY 94-8862

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 November 17, 2020

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Bayer AG

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Data from Phase III FIDELIO-DKD Study Presented at the American Society of Nephrology (ASN)’s Kidney Week 2020

Details:

The FIDELIO-DKD study, which evaluated the efficacy and safety of finerenone versus placebo when added to standard of care in patients with CKD and T2D, is the first large contemporary positive outcomes study in patients with CKD and T2D

Lead Product(s): Finerenone

Therapeutic Area: Nephrology Product Name: BAY 94-8862

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 23, 2020

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Boehringer Ingelheim GmbH

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Boehringer Ingelheim's and Lilly's New Jardiance® Findings Showed Improved Cardio-Renal Outcomes in Adults with Heart Failure with Reduced Ejection Fraction Regardless of ...

Details:

Jardiance reduced the risk of adverse cardiovascular and kidney events in adults with heart failure with reduced ejection fraction – with and without diabetes – regardless of CKD status at baseline.

Lead Product(s): Empagliflozin

Therapeutic Area: Nephrology Product Name: Jardiance

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Eli Lilly

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 23, 2020

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Bayer AG

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Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients with Chronic Kidney Disease and T2D

Details:

The results show that the investigational drug finerenone delayed the progression of CKD by significantly reducing the combined risk of time to first occurrence of kidney failure.

Lead Product(s): Finerenone

Therapeutic Area: Nephrology Product Name: BAY 94-8862

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 09, 2020

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Boehringer Ingelheim GmbH

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US FDA grants Fast Track designation to Jardiance®

Details:

The EMPA-KIDNEY clinical study is evaluating Jardiance for the progression of kidney disease and the occurrence of cardiovascular death in adults with established CKD with and without diabetes.

Lead Product(s): Empagliflozin

Therapeutic Area: Nephrology Product Name: Jardiance

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Eli Lilly

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 12, 2020

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