2021-07-07| Trials & Approvals

Eli Lilly and Boehringer Ingelheim’s Jardiance Shows Encouraging Phase 3 HFpEF Data

by Rajaneesh K. Gopinath
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Statistics suggest that heart failure affects over 60 million patients worldwide, and about half of them suffer from heart failure with preserved ejection fraction (HFpEF). Coronary artery disease, the most common form of heart disease, is the predominant cause of heart failure.

Patients with HFpEF have normal heart contractions, but the heart can’t pump enough blood and supply oxygen to all parts of the body due to the low volume of blood entering the ventricles. Although it’s a common type of heart failure, there is currently no approved treatment for it. HFpEF is one of the symptoms of cardiovascular disease and is classified as “the single largest unmet need in cardiovascular medicine.”


Jardiance Impresses in HFpEF Trial

On July 6th, Eli Lilly and Boehringer Ingelheim announced positive results from a Phase 3 trial that evaluated the safety and efficacy of Jardiance (empagliflozin), their sodium-glucose cotransporter-2 (SGLT-2) inhibitor in patients with HFpEF.

Jardiance is an FDA-approved drug used for treating type 2 diabetes. In 2016, it bagged approval for a second indication – to reduce cardiovascular death in adults with type 2 diabetes. Now, the companies report that Jardiance met the primary endpoint of the EMPEROR-Preserved trial. The trial enrolled 5,988 subjects randomized to either receive 10 mg of Jardiance daily or a placebo. Study results establish Jardiance as the only therapy to significantly reduce the risk of cardiovascular death or hospitalization in HFpEF patients with or without diabetes.

“Jardiance was the first SGLT-2 inhibitor to reduce cardiovascular death for people with type 2 diabetes and cardiovascular disease, and we have now reached another important milestone, this time in heart failure,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly.

“The EMPEROR-Preserved results offer promise in a type of heart failure that until now has traditionally been very challenging to treat effectively. The EMPEROR heart failure studies are part of our EMPOWER clinical trial program exploring the effect of Jardiance across a spectrum of cardio-renal-metabolic diseases, aiming to significantly improve outcomes in these highly prevalent conditions that impact many people’s lives.”

The detailed results would be presented at the European Society of Cardiology (ESC) Congress 2021 in August.


First Therapy to Treat Across the Full Heart Failure Spectrum

Jardiance had previously registered impressive results in the EMPEROR-Reduced trial by significantly reducing the risk of cardiovascular death or hospitalization in patients with heart failure with reduced ejection fraction (HFrEF). This makes it a potential candidate to become the world’s first drug to treat full heart failure across the spectrum, challenging fellow SGLT-2 inhibitors, Novartis’ Entresto and AstraZeneca’s Farxiga.

Originally approved as a heart failure drug in 2015, Entresto bagged FDA okay for two more indications in the past two years, including approval to treat those with HFrEF and HFpEF. The drug is expected to generate about $3 billion in annual revenue. Meanwhile, AstraZeneca’s Farxiga, which was approved in June 2020 to treat patients with HFrEF, is also dominating the market.

In January 2021, the FDA had also approved Verquvo, a drug from Merck (known as MSD outside the US and Canada), for treating patients with HFrEF. With encouraging results in the Phase 3 study, now Jardiance is making a case to enter the competition.

“No approved therapies have been clinically proven to improve outcomes specifically for people with HFpEF, leaving a significant unmet medical need in this already prevalent and increasingly common form of heart failure,” said Mohamed Eid, vice president, Boehringer Ingelheim.

“The totality of the data from the EMPEROR-Preserved trial marks a possible new chapter in heart failure, supporting the potential of Jardiance to become the first SGLT-2 inhibitor to treat a defined population of adults with heart failure with either preserved or reduced ejection fraction,” he added.

Related Article: FDA Rejection of Type 1 Diabetes Drug Impacts Provention Bio’s Stocks


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