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JardianceChronic heart failure in patients with reduced ejection fraction, and with or without type 2 diabetes

Information

Jardiance
Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Launched
Launched
Launched
July 2021
Aug 21Approved in US [16]
Jul 21Approved in EU [15].
Jul 21Licence extension approved by the MHRA. The new indication is use in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction [14].
May 21Recommended for EU approval by CHMP – the new indication is ‘Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction’ [13].
Jan 21US FDA accepts a sNDA for empagliflozin to reduce risk of CV death and hospitalisation for heart failure in adults with chronic heart failure with reduced ejection fraction, including those with and without type 2 diabetes [12].
Aug 20Filings planned by end of 2020 [11].
Jun 19US FDA grants Fast Track designation [6].

Category

Sodium glucose co-transporter type 2 (SGLT-2) inhibitor
Prevalence of asymptomatic ventricular dysfunction is approximately 4%. 1-2% of the adult population in developed countries have heart failure, with the prevalence rising to 10% in patients 70 years of age or older. Community estimates of prevalence vary from 1.6 to 4.6 cases per 1,000 in men aged 45-74 years and from 0.9 to 2.2 cases per 1,000 in women [1].
Chronic heart failure in patients with reduced ejection fraction, and with or without type 2 diabetes
Oral

Further information

Yes

Trial or other data

Oct 20PIII EMPEROR-Reduced study is published; the RCT (n=3730, class II-IV heart failure, ejection fraction ≤40%) found empagliflozin in addition to standard treatments reduced risk & total number of inpatient and outpatient worsening heart failure events (415 vs 519 patients, respectively; HR 0.76, 95% CI,0.67-0.87;p<0.0001) [10].
Jul 20PIII EMPEROR-Reduced trial has met its primary endpoint, demonstrating that empagliflozin is superior to placebo at reducing CV death or heart failure-related hospitalisation when added to standard of care (composite outcome) [9].
Mar 20PIII EMPEROR-Reduced study has finished recruiting; collection of primary outcome data now expected to complete Jun 20 [8].
Sep 19Data from a real-world study presented at the European Association for the Study of Diabetes annual meeting reported empagliflozin reduced the risk of heart failure hospitalisations by 26% vs GLP-1s [7].
May 19Estimated study completion date for EMPEROR-Preserved and EMPEROR-Reduced now Dec 19 [5].
Mar 18Boehringer Ingelheim announce expansion of the heart failure clinical trial program for empagliflozin. Two PIII randomised, placebo-controlled trials will assess the effect of empagliflozin on heart failure symptoms as well as the ability of people with heart failure to perform daily exercise, by measuring change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes. EMPERIAL-preserved [NCT03448406] will enrol patients (n=300) with preserved ejection fraction and EMPERIAL-reduced [NCT03448419] will enrol patients (n=300) with reduced ejection fraction. The trials are due to complete H1 2019 [4].
Jul 17EMPEROR-Preserved and EMPEROR-Reduced are currently recruiting. Collection of primary outcome data is expected to complete in Jun 20 [3].
Mar 17Boehringer Ingelheim initiates the EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) HF trial programme to evaluate once daily empagliflozin in heart failure patients, both with and without type 2 diabetes receiving current standard of care. The programme comprises of the two PIII, randomised, double-blind trials which will assess heart failure in patients with preserved ejection fraction (EMPEROR-Preserved; NCT03057951) or patients with reduced ejection fraction (EMPEROR-Reduced; NCT03057977). EMPEROR-Preserved trial is designed to enrol 4,126 patients in the US and Colombia; EMPEROR-Reduced trial will enrol 2,850 patients. Primary endpoint is time to first event of adjudicated CV death or adjudicated hospitalisation for heart failure [2].

Evidence based evaluations

JardianceSymptomatic chronic heart failure (CHF) in adults, independent of left ventricular ejection fraction

Information

Jardiance
Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Launched
Launched
Launched
June 2022
Jun 22MHRA approves a change to the indication for Jardiance 10mg and 25mg tablets. Now indicated in adults for the treatment of symptomatic chronic heart failure. Data from the EMPEROR-Preserved study has been added to the SmPC [22].
Feb 22Approved in US by FDA to reduce the risk of cardiovascular death and hospitalization in adults with heart failure [21]
Feb 22Licence change approved in EU [20].
Jan 22CHMP recommends a change to the indications for Jardiance to permit use in adults with symptomatic heart failure independent of left ventricular ejection fraction (previously only licensed in heart failure with reduced ejection fraction). The proposed revised indication is “Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure” [19].
Sep 21Company pipeline shows this indication is pre-registration with submissions ongoing; presume EU and US [15].
Sep 21Granted Breakthrough Therapy designation [14].
Jun 19US FDA grants Fast Track designation [6].

Category

Sodium glucose co-transporter type 2 (SGLT-2) inhibitor
Prevalence of asymptomatic ventricular dysfunction is approximately 4%. 1-2% of the adult population in developed countries have heart failure, with the prevalence rising to 10% in patients 70 years of age or older. Community estimates of prevalence vary from 1.6 to 4.6 cases per 1,000 in men aged 45-74 years and from 0.9 to 2.2 cases per 1,000 in women [1].
Symptomatic chronic heart failure (CHF) in adults, independent of left ventricular ejection fraction
Oral

Further information

Yes

Trial or other data

Jan 22Review of EMPEROR-Preserved trial found empagliflozin reduced the risk for major heart failure outcomes across the range of baseline Kansas City Cardiomyopathy Questionnaire scores. The improvements in health-related quality of life were sustained for at least 1 year [18].
Nov 21A new sub-analysis of the EMPEROR-Preserved PIII trial reports empagliflozin reduced the risk for the composite primary endpoint of CV death or hospitalisation for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) >40% regardless of chronic kidney disease status at baseline [17]
Sep 21Results of PIII EMPEROR study reported in Circulation [13].
Sep 21PIII EMPEROR study (n=5988), found empagliflozin was associated with a reduced risk of the combined endpoint of CV death or hospitalisation for heart failure (13.8% v 17.1% placebo; HR 0.79; 95% CI 0.69-0.90; p40% [12].
Jul 21Topline results from the PIII EMPEROR-Preserved trial, show empagliflozin significantly reduced risk of cardiovascular (CV) death or hospitalisation for HF in patients with HF with preserved reduced ejection fraction (HFpEF) [10].
Jan 21PIII EMPEROR-Preserved study is ongoing with estimated primary completion date of Mar 21 [9]
Mar 20PIII EMPEROR-Preserved study is recruiting; collection of primary outcome data now expected to complete Oct 20 [8].
Sep 19Data from a real-world study presented at the European Association for the Study of Diabetes annual meeting reported empagliflozin reduced the risk of heart failure hospitalisations by 26% vs GLP-1s [7].
May 19Estimated study completion date for EMPEROR-Preserved and EMPEROR-Reduced now Dec 19 [5].
Mar 18Boehringer Ingelheim announce expansion of the heart failure clinical trial program for empagliflozin. Two PIII randomised, placebo-controlled trials will assess the effect of empagliflozin on heart failure symptoms as well as the ability of people with heart failure to perform daily exercise, by measuring change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes. EMPERIAL-preserved [NCT03448406] will enrol patients (n=300) with preserved ejection fraction and EMPERIAL-reduced [NCT03448419] will enrol patients (n=300) with reduced ejection fraction. The trials are due to complete H1 2019 [4].
Jul 17EMPEROR-Preserved and EMPEROR-Reduced are currently recruiting. Collection of primary outcome data is expected to complete in Jun 20 [3].
Mar 17Boehringer Ingelheim initiates the EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) HF trial programme to evaluate once daily empagliflozin in heart failure patients, both with and without type 2 diabetes receiving current standard of care. The programme comprises of the two PIII, randomised, double-blind trials which will assess heart failure in patients with preserved ejection fraction (EMPEROR-Preserved; NCT03057951) or patients with reduced ejection fraction (EMPEROR-Reduced; NCT03057977). EMPEROR-Preserved trial is designed to enrol 4,126 patients in the US and Colombia; EMPEROR-Reduced trial will enrol 2,850 patients. Primary endpoint is time to first event of adjudicated CV death or adjudicated hospitalisation for heart failure [2].

Evidence based evaluations

JardianceChronic kidney disease in patients with or without type 2 diabetes

Information

Jardiance
Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Sodium glucose co-transporter type 2 inhibitor. Mechanisms in kidney disease not yet full understood, but the EMPA-REG OUTCOME trial had positive results for patients with chronic kidney disease, including reduction in glomerular pressure [1].
Chronic kidney disease is highly prevalent in various parts of the world, affecting approx. 10-15% of the population [1].
Chronic kidney disease in patients with or without type 2 diabetes
Oral

Further information

Yes

Evidence based evaluations

JardianceType 2 diabetes mellitus in children and adolescents

Information

Jardiance
Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Sodium glucose co-transporter type 2 (SGLT-2) inhibitor
About 36,000 children and young people under the age of 19 years have diabetes in the UK, of which about 10% have type 2 diabetes (or other rarer types of diabetes) [1].
Type 2 diabetes mellitus in children and adolescents
Oral

JardianceAcute myocardial infarction (MI)

Information

Jardiance
Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Sodium glucose co-transporter type 2 (SGLT-2) inhibitor
Over 200,000 hospital visits each year are due to myocardial infarction. In 2014, the UK Clinical Practice Research Datalink GOLD database produced data suggesting that the prevalence of myocardial infarction was 2.46% in men of all ages, and 0.87% in women of all ages [1].
Acute myocardial infarction (MI)
Oral

JardianceAcute stabilised heart failure in patients with or without T2D

Information

Jardiance
Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Apr 22Company has no plans to file for a separate indication based on the EMPULSE trial [6].

Category

Selective sodium glucose co-transporter type 2 (SGLT2) inhibitor
Acute heart failure is a common cause of admission to hospital (over 67,000 admissions in England and Wales a year) and is the leading cause of hospital admission in people 65 years or older in the UK [2].
Acute stabilised heart failure in patients with or without T2D
Oral