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Jardiance

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    Drug Pipelines

  • 43 Pages
  • February 2019
  • Region: Global
  • Citeline
  • ID: 4462145
Drug Overview
Jardiance (empagliflozin; Boehringer Ingelheim/Eli Lilly) is a sodium-glucose cotransporter-2 (SGLT-2) inhibitor originally developed by Boehringer Ingelheim for the treatment of type 2 diabetes. As part of the companies’ strategic diabetes alliance, Jardiance’s late-stage development and commercialization was conducted with Eli Lilly. The drug is jointly marketed by both companies. In August 2014, Eli Lilly and Boehringer Ingelheim received regulatory approval from the US Food and Drug Administration, having previously been issued a complete response letter in March 2014. The drug was initially rejected due to previously identified failings at a Boehringer Ingelheim manufacturing facility.

The European Commission approved the drug in May 2014.

Jardiance exerts its pharmacological effect by inhibiting SGLT-2, which is expressed almost exclusively in the kidney. Located in the proximal tubule, the SGLT-2 transport system is involved in the reabsorption of glucose. As such, inhibition of the transport protein prevents glucose reabsorption, resulting in excretion through the urine. The drug has also demonstrated improvements in cardiovascular (CV) outcomes in type 2 diabetes patients at high risk of, or with a history of, adverse CV events.

Plans have also been announced for a Phase III trial of Jardiance for the treatment of chronic kidney disease, including diabetic nephropathy.

Table of Contents

OVERVIEW
Drug Overview
Product Profiles
Jardiance : Diabetic nephropathy
Jardiance : Chronic heart failure (CHF)
Jardiance : Diabetes type 2
LIST OF FIGURES
Figure 1: The authors drug assessment summary of Jardiance for diabetic nephropathy
Figure 2: The authors drug assessment summary of Jardiance for diabetic nephropathy
Figure 3: Jardiance sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country, 2017–26
Figure 4: Jardiance for chronic heart failure – SWOT analysis
Figure 5: The authors drug assessment summary of Jardiance for chronic heart failure
Figure 6: The authors drug assessment summary of Jardiance for chronic heart failure
Figure 7: Jardiance sales for chronic heart failure across the US, Japan, and five major EU markets, by country, 2017–26
Figure 8: Jardiance for type 2 diabetes – SWOT analysis
Figure 9: The authors drug assessment of Jardiance
Figure 10: The authors drug assessment scorecard for Jardiance compared to Januvia
Figure 11: Jardiance sales for type 2 diabetes across the US, Japan, and five major EU markets, by country, 2016–25
Figure 12: Synjardy sales for type 2 diabetes across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
Table 1: Jardiance drug profile
Table 2: Jardiance Phase III trial in chronic kidney disease, including diabetic nephropathy
Table 3: Jardiance for diabetic nephropathy – SWOT analysis
Table 4: Jardiance drug profile
Table 5: Jardiance Phase III trials in chronic heart failure
Table 6: Jardiance sales for chronic heart failure across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 7: Jardiance drug profile
Table 8: Overview of published pivotal trial data for Jardiance in diabetes
Table 9: Pooled analysis of data from four Phase III Jardiance clinical trials
Table 10: Key endpoint data from the EMPA-REG OUTCOME trial
Table 11: Jardiance sales for type 2 diabetes across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 12: Synjardy sales for type 2 diabetes across the US, Japan, and five major EU markets, by country ($m), 2016–25

Companies Mentioned

  • Boehringer Ingelheim
  • Eli Lilly