The treatment is indicated to reduce the risk of cardiovascular death and hospitalization in a wider range of adult patients with heart failure.
The US Food and Drug Administration (FDA) has approved empagliflozin (Jardiance) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients.
The approval for empagliflozin was granted to Boehringer Ingelheim.
Previously, empagliflozin was approved by the FDA in 2014 as a supplement to diet and exercise in order to improve glucose control in adults with type 2 diabetes (T2D). The treatment is additionally approved to reduce the risk of cardiovascular death in adults with T2D and established cardiovascular disease and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction.
The treatment can be initiated in adults with heart failure with an eGFR as low as 20 mL/min/1.73 m2.
In a statement, Norman Stockbridge, MD, PhD, Director of the Division of Cardiology and Nephrology, FDA Center for Drug Evaluation and Research, noted the approval will provide a treatment option for a wider range of patients with heart failure.
“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,” Stockbridge said. “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 approval evaluated empagliflozin's safety and effectiveness as an adjunct to standard of care therapy in the phase 3 EMPEROR-Preserved trial. Participants who received empagliflozin 10 mg once-daily (n = 2,997) were compared to participants who received the placebo (n = 2991). The main efficacy measurements included the time-to-death from cardiovascular causes or need to be hospitalized for heart failure.
Reported data from the trial show that of the individuals who received empagliflozin for an average of 2 years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of participants who received the placebo. It was noted that “this benefit was mostly attributable to fewer patients being hospitalized for heart failure.”
"In its phase III 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, MD, chairman, Department of Medicine, University of Mississippi in a statement. "Today's approval means these demonstrated benefits can now help to address a significant unmet need for the approximately 3 million adults in the U.S. with preserved ejection fraction, a form of heart failure that has very limited treatment options."
Side effects in clinical studies with empagliflozin for patients with heart failure were consistent with side effects for patients with diabetes. The most common adverse events in patients with diabetes were urinary tract infections and female fungal infections. Symptoms of heart failure can include shortness of breath, fatigue, and swelling in the legs.
More than 650,000 people in the United States are affected by heart failure with high mortality rates, highlighting the need for more treatment options for a broader range of patients. Heart failure is more common with age and is the leading cause of hospitalization in patients over 65 years.
The agent received Priority Review for this indication.