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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
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.
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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
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.
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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
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
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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
Details:
Finerenone significantly reduced the risk of the composite primary endpoint of time to kidney failure or renal death by 18% over a median duration of follow-up of 2.6 years when added to maximum tolerated dose of guideline-directed therapy.
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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
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.
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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
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.
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Lead Product(s): Empagliflozin
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 12, 2020
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.
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