The European Commission (EC) has granted marketing authorisation to Boehringer Ingelheim and Eli Lilly and Company’s Jardiance (empagliflozin) to treat symptomatic chronic heart failure in adult patients.
With the latest development, Jardiance became the first treatment to be approved for use in all adult patients with symptomatic chronic heart failure.
The treatment population comprises patients across the complete left ventricular ejection fraction (LVEF) spectrum, including heart failure with reduced and preserved ejection fraction (HFrEF and HFpEF).
Administered once a day, empagliflozin is an oral, highly selective inhibitor of sodium-glucose cotransporter 2 (SGLT2).
Furthermore, it is the first Type 2 diabetes treatment to have cardiovascular death risk reduction data in its label in various nations.
The EC based its approval on data from the Phase III EMPEROR-Preserved clinical trial that assessed 10mg empagliflozin versus placebo, both given along with the standard of care.
It enrolled a total of 5,988 adult heart failure subjects with over 40% LVEF.
According to the findings, empagliflozin showed to offer a 21% relative decline in risk for the composite primary endpoint of cardiovascular mortality or hospital admission due to heart failure.
Earlier, the oral therapy obtained approval to treat symptomatic chronic HFrEF in adults.
Boehringer Ingelheim CardioMetabolic Medicine corporate vice-president and head Waheed Jamal said: “The European approval will redefine the standard of care for millions of people in the EU living with heart failure.
“This approval reinforces empagliflozin’s potential to transform the lives of adults with chronic heart failure and builds on Boehringer Ingelheim and Lilly’s legacy of leadership in this space.”
The latest development comes after Jardiance obtained approval from the US Food and Drug Administration (FDA) to reduce cardiovascular death and hospital admission risk in adult patients with heart failure.