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Lead Product(s): Empagliflozin
Therapeutic Area: Cardiology/Vascular Diseases 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 January 11, 2021
Details:
The sNDA is based on results from the EMPEROR-Reduced phase III trial, in which Jardiance was associated with a significant 25% relative risk reduction in the primary composite endpoint of time to cardiovascular death or hospitalization due to heart failure.
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Lead Product(s): Empagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Jardiance
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 September 15, 2020
Details:
This Fast Track designation for empagliflozin emphasizes the urgent need for potential treatments that may improve outcomes following an acute myocardial infarction, more commonly known as a heart attack, in adults with and without diabetes.
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Lead Product(s): Empagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: BI10773
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 August 29, 2020
Details:
Full results from the EMPEROR-Reduced phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, showed that Jardiance® (empagliflozin) was associated with a significant 25% relative risk reduction in the primary endpoint of time to cardiovascular death or hospitalization due to heart failure.
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Lead Product(s): Vericiguat
Therapeutic Area: Cardiology/Vascular Diseases Product Name: BAY 1021189
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 August 28, 2020
Details:
Vericiguat is an investigational oral, once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45%.
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Lead Product(s): Empagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Jardiance
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 31, 2020
Details:
Empagliflozin significantly reduced the risk of cardiovascular death or hospitalization for heart failure versus placebo in the EMPEROR-Reduced heart failure trial. The study evaluated adults with heart failure with reduced ejection fraction
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Lead Product(s): Empagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: BI10773
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 July 30, 2020
Details:
Empagliflozin significantly reduced the risk of cardiovascular death or hospitalization for heart failure versus placebo in the EMPEROR-Reduced heart failure trial. The study evaluated adults with heart failure with reduced ejection fraction.
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Lead Product(s): Finerenone
Therapeutic Area: Cardiology/Vascular Diseases 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 15, 2020
Details:
FINEARTS-HF is the first large-scale, long-term study to investigate the non-steroidal, selective mineralocorticoid receptor antagonist finerenone on morbidity and mortality outcomes in a heart failure patient population.
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Lead Product(s): Vericiguat
Therapeutic Area: Cardiology/Vascular Diseases 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:
Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England Journal of Medicine.
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