Jardiance
Publisher: Datamonitor Healthcare
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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.
Analyst Outlook
Jardiance (empagliflozin; Boehringer Ingelheim/Eli Lilly) is somewhat late to the game in diabetic nephropathy (DN), with a pivotal chronic kidney disease (CKD) trial announced, but not yet started, putting it in line to be the third sodium-glucose cotransporter-2 (SGLT-2) inhibitor with a renal indication. Still, this could be mitigated by recommendations from a 2018 ADA/EASD consensus report for use of Jardiance and Invokana (canagliflozin; Johnson & Johnson/Mitsubishi Tanabe/Daiichi Sankyo) in DN based on renal results in their cardiovascular outcomes trials (CVOTs). While the inclusion of non-diabetic patients in the pivotal trial adds some uncertainty, in the interim, share gains due to Jardiance’s positive EMPA-REG CVOT in patients with type 2 diabetes and CV disease, as well as expected positive results in heart failure (HF) pivotal trials, should spill over to DN patients where these are important co-morbidities, though Farxiga (dapagliflozin; AstraZeneca/Ono Pharmaceutical) is also being studied in HF. If the HF trials confirm a benefit in heart failure with preserved ejection fraction (HFpEF), as suggested by Farxiga’s CVOT in type 2 diabetes, it could be a particular boon, as there are limited treatment options for this segment.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Jardiance : Diabetic nephropathy
17 Jardiance : Chronic heart failure (CHF)
27 Jardiance : Diabetes type 2
LIST OF FIGURES
12 Figure 1: Datamonitor Healthcare’s drug assessment summary of Jardiance for diabetic nephropathy
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Jardiance for diabetic nephropathy
15 Figure 3: Jardiance sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country, 2017–26
20 Figure 4: Jardiance for chronic heart failure – SWOT analysis
21 Figure 5: Datamonitor Healthcare’s drug assessment summary of Jardiance for chronic heart failure
22 Figure 6: Datamonitor Healthcare’s drug assessment summary of Jardiance for chronic heart failure
24 Figure 7: Jardiance sales for chronic heart failure across the US, Japan, and five major EU markets, by country, 2017–26
34 Figure 8: Jardiance for type 2 diabetes – SWOT analysis
35 Figure 9: Datamonitor Healthcare drug assessment of Jardiance
36 Figure 10: Datamonitor Healthcare drug assessment scorecard for Jardiance compared to Januvia
38 Figure 11: Jardiance sales for type 2 diabetes across the US, Japan, and five major EU markets, by country, 2016–25
40 Figure 12: Synjardy sales for type 2 diabetes across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
7 Table 1: Jardiance drug profile
9 Table 2: Jardiance Phase III trial in chronic kidney disease, including diabetic nephropathy
11 Table 3: Jardiance for diabetic nephropathy – SWOT analysis
18 Table 4: Jardiance drug profile
19 Table 5: Jardiance Phase III trials in chronic heart failure
25 Table 6: Jardiance sales for chronic heart failure across the US, Japan, and five major EU markets, by country ($m), 2017–26
28 Table 7: Jardiance drug profile
29 Table 8: Overview of published pivotal trial data for Jardiance in diabetes
32 Table 9: Pooled analysis of data from four Phase III Jardiance clinical trials
33 Table 10: Key endpoint data from the EMPA-REG OUTCOME trial
39 Table 11: Jardiance sales for type 2 diabetes across the US, Japan, and five major EU markets, by country ($m), 2016–25
41 Table 12: Synjardy sales for type 2 diabetes across the US, Japan, and five major EU markets, by country ($m), 2016–25
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