FDA Expands Heart Indication for Blockbuster Jardiance

The new indication for reducing the risk of cardiovascular death and hospitalization for heart failure is expected to boost Jardiance’s sales further. Revenue for the drug jumped 38% in 2021 to reach nearly $432 million globally.

The FDA added yet another heart indication for Boehringer Ingelheim’s blockbuster Jardiance (empagliflozin).

The new indication for reducing the risk of cardiovascular death and hospitalization for heart failure is expected to boost Jardiance’s sales further. Revenue for the drug jumped 38% in 2021 to reach nearly $432 million globally.

Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes.

In addition, the medication is approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction.

“Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, M.D, Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “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.”

Jardiance’s safety and effectiveness were evaluated as an adjunct to standard of care therapy in a randomized, double-blind, international trial comparing 2,997 participants who received Jardiance, 10 mg, once daily to 2,991 participants who received the placebo.

Of the individuals who received Jardiance for an average of about two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received the placebo. “This benefit was mostly attributable to fewer patients being hospitalized for heart failure,” the FDA said.

The side effects in clinical studies with Jardiance for patients with heart failure were generally consistent with side effects for patients with diabetes. In diabetic patients, the most common adverse events were urinary tract infections and female fungal infections. Jardiance must not be used in patients who previously have had a serious allergic reaction to it as well as patients on dialysis.