At the 2021 European Society of Cardiology (ESC) Congress, full results were presented for EMPEROR-Preserved, a Phase III trial investigating Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) in heart failure with preserved ejection fraction (HFpEF). The results of this landmark trial are likely to prompt a change in clinical practice for HFpEF, a condition that is notoriously challenging to treat, with Jardiance becoming established as the preferred therapeutic option, says GlobalData, a leading data and analytics company.

Fiona Chisholm, Pharma Analyst at GlobalData, comments: “Limited therapeutic options available to HFpEF patients represents a strong unmet need within heart failure, according to key opinion leaders (KOLs) interviewed by GlobalData. Jardiance is the first drug to demonstrate a clear clinical benefit in a HFpEF trial and has real potential to improve therapeutic outcomes for patients.

“The positive outcome of the EMPEROR-Preserved study is particularly welcome news as the HFpEF field has been plagued by a number of high-profile trial failures. Recently, Novartis’ angiotensin receptor neprilysin inhibitor (ARNI), Entresto (sacubitril/valsartan), narrowly missed statistical significance in the Phase III PARAGON-HF trial. Despite this, Entresto was approved for HFpEF earlier this year in the US, indicating the low bar for new drug approvals in this space.”

Jardiance, which is already marketed for the treatment of heart failure with reduced ejection fraction (HFrEF) and type 2 diabetes (T2D), is almost certain to achieve a label expansion for HFpEF, and Boehringer Ingelheim and Eli Lilly have announced plans for regulatory submissions for this year. Jardiance has a clear competitive advantage over Entresto in the HFpEF space and is likely to become the treatment of choice for many patients. However, Boehringer Ingelheim and Eli Lilly will have to address the potential threat posed by AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin). DELIVER, a Phase III trial investigating Farxiga in HFpEF, is currently ongoing and is expected to complete in Q1 2022.

Chisholm adds: “With the threat of Farxiga in sight, Boehringer Ingelheim and Eli Lilly will be keen to expedite approval of Jardiance in HFpEF. Establishing a first-mover advantage over Farxiga will represent a key priority if the DELIVER trial results demonstrate that Farxiga confers a similar benefit to Jardiance in HFpEF.”