FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure
Eli Lilly and Boehringer Ingelheim's blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider range of heart failure patients.
The approval builds upon previously secured indications, including the use of Jardiance to reduce the risk of cardiovascular death plus hospitalisation for heart failure with reduced left ventricular ejection fraction (LVEF), which the FDA greenlighted in 2021.
With the expanded indication, Jardiance is the only drug to be cleared to improve outcomes in all heart failure patients, no matter their ejection fraction status.
The FDA initially approved the drug in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Jardiance is also authorised to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
According to the FDA, heart disease impacts more than 650,000 people in the US each year. Despite advancements in treatment in multiple drug classes, mortality remains a significant issue and treatment options for a broader range of patients are needed.
"While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure," says Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA's Center for Drug Evaluation and Research. "Coinciding with February's annual observance of American Heart Month—a reminder for individuals to focus on cardiovascular health—this action will provide physicians another tool to address heart disease."
The FDA's decision to expand the indications for Jardiance was based on results from the international, randomised, double-blind EMPEROR-Preserved phase III trial, which evaluated the safety and efficacy of Jardiance 10mg compared to placebo and standard of care therapy.
Endpoint analysis from EMPEROR-Preserved shows that in 5,988 adults with heart failure with LVEF over 40%, the once-daily dose of Jardiance demonstrated a 21% relative risk reduction (3.3% absolute risk reduction, 0.79 HR, 0.69-0.90 95% CI) for the composite primary endpoint of cardiovascular death or hospitalisation for heart failure.
The study also showed that Jardiance reduced the relative risk of first and recurrent hospitalisations for heart failure by 27%.
"In its phase 3 trials, empagliflozin has shown a statistically significant and clinically meaningful benefit in patients with heart failure across the spectrum of ejection fraction," said Javed Butler, M.D, chairman, Department of Medicine, University of Mississippi. "Today's approval means these demonstrated benefits can now help to address a significant unmet need for the approximately three million adults in the US with preserved ejection fraction, a form of heart failure that has very limited treatment options."
