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Lilly","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Accepts Supplemental New Drug Application and Grants Priority Review for Jardiance\u00ae For Adults with Heart Failure Independent of Left Ventricular Ejection Fraction","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Boehringer Ingelheim GmbH"}]
Details:
Jardiance is currently indicated to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction.
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
November 11, 2021
Details:
Jardiance® (empagliflozin) has been granted marketing authorization by Health Canada as a treatment for heart failure with reduced ejection fraction (HFrEF), as an adjunct to standard of care therapy.
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
November 02, 2021
Details:
Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction.
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
September 09, 2021
Details:
In this clinical first for adults with heart failure with preserved ejection fraction, empagliflozin demonstrated an impressive 21 percent relative risk reduction in the composite primary endpoint of cardiovascular death or hospitalization for heart failure.
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
August 27, 2021
Details:
Interim analysis of the EMPRISE real-world evidence study showed that empagliflozin was associated with a reduced risk in all-cause mortality, hospitalization for heart failure and acute kidney injury requiring dialysis, compared to DPP-4 inhibitors.
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
June 28, 2021
Details:
Marketing authorization is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction in the combined relative risk versus placebo of cardiovascular death or hospitalization due to heart failure.
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
June 21, 2021
Details:
The positive opinion is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction in the combined relative risk of cardiovascular death or hospitalization due to heart failure.
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
May 22, 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.
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:
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.
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:
Full results from EMPEROR-Reduced phase III trial of Jardiance® (empagliflozin) in adults with heart failure with reduced ejection fraction, with and without diabetes, showed a significant 25% relative risk reduction in primary endpoint of time to cardiovascular death.
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
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