Jardiance (Empagliflozin) Marks First Breakthrough in Treating Heart Failure with Preserved Ejection Fraction (HFpEF)

July 06, 2021 /BioValleyBIOON/ -- Boehringer Ingelheim andEli Lilly(Eli Lilly) recently jointly announced that the Phase 3 EMPEROR-Preserved trial, evaluating the SGLT2 inhibitor Jardiance (Chinese trade name: Outangjing; generic name: empagliflozin) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF), has met its primary endpoint.

Based on these results,Jardiance is the first and only to significantly reduce in patients with HFpEF (with or withoutDiabetes mellitus）therapy for the composite risk of cardiovascular death or hospitalization for heart failure.Combined with the results of the EMPEROR-Reduced trial,These findings confirm the efficacy of Jardiance in all types of heart failure, regardless of ejection fraction.In the EMPEROR-Preserved trial, the safety of Jardiance was generally consistent with its known safety profile.

The EMPEROR-Preserved trial compared a 10 mg dose of Jardiance with placebo, with full results scheduled to be presented on August 27 at the 2021 European Society of Cardiology (ESC) Congress. Boehringer Ingelheim andEli LillyA regulatory application for Jardiance for the treatment of HFpEF is planned for submission in 2021.

The results of the EMPEROR-Preserved trial complement those of the prior Phase 3 EMPEROR-Reduced trial, which demonstrated that, in adult patients with heart failure with reduced ejection fraction (HFrEF), Jardiance significantly reduced the relative risk of the composite of cardiovascular death or hospitalization for heart failure by 25% compared with placebo. In summary,These studies have demonstrated the benefits of Jardiance across the entire heart failure disease spectrum (including patients with HFrEF and HFpEF).

Mohamed Eid, Vice President of Clinical Development and Medical Affairs at Boehringer Ingelheim, stated: "Currently, there is no approved treatment that can improve the prognosis of patients with HFpEF, leaving a significant unmet medical need for patients with this already prevalent and increasingly common form of heart failure."Data from the EMPEROR-Preserved trial may mark a new chapter in heart failure., supporting the potential of Jardiance to become the first SGLT2 inhibitor to treat adults with heart failure with preserved or reduced ejection fraction.”

Eli LillyVice President of Product Development Jeff Emmick stated: “Jardiance is the first to reduce risk in type 2 diabetes with cardiovascular diseaseDiabetes mellitusFor SGLT2 inhibitors in reducing cardiovascular mortality in patients, we have now reached another important milestone, this time in heart failure. The results of the EMPEROR-Preserved trial demonstrate the potential for treating a type of heart failure (HFpEF), whose effective management has remained highly challenging until now. The EMPEROR heart failure studies are our EMPOWERClinical Trialpart of the project, aimed at exploring the effects of Jardiance on a range of cardiorenal-metabolic diseases, to significantly improve the prognosis of these highly prevalent conditions that affect the lives of many people.”

In June this year, Jardiance was approved in the European Union for a new indication: for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF, systolic heart failure), regardless of the presence or absence of type 2 diabetes.Diabetes。Currently, a supplemental New Drug Application (sNDA) for Jardiance is also under review by the U.S.FDAReview of: as a potential new therapy for adult patients with HFrEF, including those with and without type 2Diabetes mellituspatients, reducing the risk of cardiovascular death and hospitalization for heart failure, and slowing the decline in renal function.

In October 2020, Boehringer Ingelheim-Eli LillyAnnounced the submission of a marketing authorization application to China's National Medical Products Administration (NMPA) for Jardiance for the treatment of adult patients with heart failure with reduced ejection fraction (HFrEF), with or without diabetes.This is the second indication application for Jardiance in China. The regulatory submission for this indication was synchronized with filings in the United States and the European Union, occurring just six days after the US submission, which places it at the forefront of the industry. Previously, Jardiance was granted marketing approval in China in September 2017 for the treatment of type 2 diabetes mellitus. As an adjunct to diet and exercise, it may be used as monotherapy, in combination with metformin, or in combination with metformin and a sulfonylurea to improve glycemic control in patients with type 2 diabetes.

The approval of a new indication for Jardiance in the treatment of HFrEF is based on the results of the Phase 3 EMPEROR-Reduced trial (NCT03057977). The trial was conducted in adult patients with HFrEF (with or without diabetes), and data showed that the study met its primary endpoint:When used in combination with standard of care, Jardiance 10 mg significantly reduced the risk of recurrent cardiovascular death or hospitalization for heart failure by 25% compared with placebo.Results for the primary endpoint were consistent across patient subgroups with and without type 2 diabetes (T2D). Analysis of the key secondary endpoints showed that,Compared with placebo, Jardiance reduced the relative risk of first and recurrent hospitalizations for heart failure by 30% and significantly slowed the decline in renal function.In this trial, the safety profile of Jardiance was consistent with its known safety profile.

EMPEROR-Reduced: Primary Endpoint and Heart Failure Hospitalization Results

Heart failure (HF) affects over 60 million people worldwide, with significant unmet medical needs remaining in treatment, as approximately half of diagnosed patients are expected to die within 5 years. HF is the leading cause of hospitalization among adults aged 65 and older. HF is the most common and severe complication following a heart attack, occurring when the heart is unable to pump sufficient blood to the rest of the body. Patients with HF frequently experience shortness of breath and fatigue, which significantly impair their quality of life.

Patients with HF often also have renal impairment, which can significantly adversely affect prognosis. The mortality risk for HF patients increases with each hospitalization. Heart failure with reduced ejection fraction (HFrEF) occurs when the myocardium cannot contract effectively, resulting in less blood being pumped from the heart into the body compared to a normally functioning heart. Heart failure with preserved ejection fraction (HFpEF) occurs when the myocardium contracts normally but the ventricles do not fill with sufficient blood, resulting in less blood entering the heart compared to a normally functioning heart.

The EMPOWER clinical program is the most extensive and comprehensive among all SGLT2 inhibitors, exploring the impact of Jardiance on the lives of patients with cardiorenal-metabolic diseases.

Jardiance (Outangjing, empagliflozin) is an oral, once-daily, highly selective SGLT2 inhibitor. The emerging class of SGLT2 inhibitors has been demonstrated to inhibit renal glucose reabsorption, promoting the urinary excretion of excess glucose to lower blood glucose levels. Moreover, this glucose-lowering effect is independent of β-cell function and insulin resistance. Beyond its well-established glycemic efficacy, the drug offers additional benefits, including weight reduction, blood pressure lowering, and uric acid reduction. Jardiance exhibits a favorable safety profile and reduces the risk of cardiovascular events in patients with diabetes. It is the first type 2 diabetes medication globally proven by clinical research to reduce the risk of cardiovascular death.

Jardiance was approved for marketing in August 2014 for the treatment of patients with type 2 diabetes. In late 2016, Jardiance received additional approval to reduce the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease. In recent years,Eli Lilly- The Boehringer Ingelheim alliance has been committed to developing this drug for the treatment of heart failure and chronic kidney disease. (Bioon.com)

Original Source:Breakthrough results for Jardiance? (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction