Eli Lilly and Boehringer Ingelheim have revealed positive results from a Phase III study of its SGLT2 inhibitor Jardiance in patients with heart failure with preserved ejection fraction (HFpEF).
The EMPEROR-Preserved trial has shown Jardiance (empagliflozin) can significantly reduce the risk of cardiovascular death or hospitalisation in adults living with HFpEF, with or without diabetes.
In a statement, the two pharma companies said the results establish Jardiance as the first SGLT2 inhibitor treatment to show benefit for HFpEF patients.
“The EMPEROR-Preserved topline results represent a significant breakthrough in cardiovascular medicine and for people with heart failure, which is an increasingly prevalent public health issue affecting millions of people worldwide,” said Iain Squire, lead investigator for EMPEROR-Preserved in the UK.
“HFpEF has been the most challenging form of heart failure to treat, given the lack of evidence-based treatments up until now. The findings from EMPEROR-Preserved demonstrate the potential of Jardiance to reduce cardiovascular death or hospitalization for heart failure with preserved ejection fraction,” he added.
Following the topline results, Lilly and Boehringer will reveal full results from the EMPEROR-Preserved trial at the upcoming European Society of Cardiology (ESC) congress in August.
The companies are also planning to file Jardiance for regulatory approvals by the end of the year.
“These highly-anticipated results demonstrate the potential of Jardiance in heart failure with preserved ejection fraction which can be devastating to those affected, impacting their daily activities while posing a greater risk of other vascular complications,” said Douglas Clark, head of medical affairs for UK and Ireland at Boehringer Ingelheim.
“The BI/Lilly Alliance is committed to exploring how we can help to support these patients and developing new treatment options for their healthcare professionals,” he added.