Last month, the FDA approved empagliflozin (Jardiance) to lower the risk of cardiovascular death and hospitalization for heart failure in adult patients.
In February, the FDA approved empagliflozin (Jardiance, Boehringer Ingelheim) to lower the risk of cardiovascular death and hospitalization for heart failure in adult patients.
Following the FDA action, empagliflozin became the first approved heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction, according to Boehringer Ingelheim.
In 2014, the FDA approved empagliflozin as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes (T2D). The treatment has also been approved to lower 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 FDA previously granted priority review for the current indication.
The treatment can be initiated in adults with heart failure with an eGFR as low as 20 mL/min/1.73 m2.
Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology, FDA Center for Drug Evaluation and Research, said the approval will offer a treatment option for a wider range of patients with heart failure.
The safety and efficacy of empagliflozin as an adjunct to standard of care therapy was evaluated in the phase 3 EMPEROR-Preserved trial. Participants administered empagliflozin 10 mg once-daily (n = 2997) were compared with participants administered a placebo (n = 2991). The main efficacy measurements included the time-to-death from cardiovascular causes or need for hospitalization for heart failure.
Among individuals who received empagliflozin for an average of 2 years, the study found that 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% who received the placebo. The investigators said this benefit was largely attributable to fewer patients being hospitalized for heart failure.
Adverse effects (AEs) in clinical studies with empagliflozin for patients with heart failure were consistent with AEs for patients with diabetes. The most common AEs 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.
US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction. Boehringer Ingelheim and Eli Lilly and Company. News release. https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jardiancer-empagliflozin-treat-adults-heart. February 24, 2022.