FDA Approves Lilly's Jardiance to Reduce Cardiovascular Death and Hospitalization Risk in Adults with Heart Failure

Today, Boehringer Ingelheim and Eli Lilly announced that the U.S. FDA has approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization in adult patients with heart failure. The related press release noted that this approval provides a new treatment option for a broader population of heart failure patients.

Heart failure is a syndrome caused by the heart's inability to meet the body's demands, with symptoms including shortness of breath, fatigue, and leg swelling. As people age, heart failure becomes increasingly common and is a leading cause of hospitalization for those over 65. Despite the availability of multiple drug classes for treatment, the mortality rate for heart failure remains high, and many patients still require new therapeutic options.

Jardiance is an SGLT2 inhibitor that was first approved by the U.S. FDA in 2014 as an adjunct treatment for adults with type 2 diabetes. Further studies have shown that this therapy prevents the reabsorption of salt, thereby increasing salt excretion in the body and reducing fluid load in the vascular system. The induced changes in glucose, salt, and water metabolism may help reduce cardiovascular death. Previously, it had also been approved for multiple indications, including reducing the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease, as well as reducing the risk of death and hospitalization in patients with heart failure and low ejection fraction. Today's approval further expands its range of use.

The approval was based on safety and efficacy data from a randomized, double-blind international clinical trial. Nearly 6,000 volunteers participated in the study, with 2,997 people using 10 mg of Jardiance daily and another 2,991 receiving a placebo. In the group that used Jardiance for an average of two years, 14% died from cardiovascular causes or were hospitalized due to heart failure, compared to 17% in the placebo group. The press release noted that the main benefit of this therapy is the reduction in the number of patients hospitalized due to heart failure.

In heart failure patients, the adverse reactions of this therapy are consistent with those faced by diabetic patients. The most common ones include urinary tract infections and female fungal infections. It cannot be used in patients undergoing dialysis treatment or in patients who have previously had a severe allergic reaction to this therapy.

References:

[1] FDA Approves Treatment for Wider Range of Patients with Heart Failure, Retrieved February 24, 2022, from https://www.prnewswire.com/news-releases/fda-approves-treatment-for-wider-range-of-patients-with-heart-failure-301489972.html

[2] US FDA approves Jardiance^® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction. Retrieved February 24, 2022, from https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jardiancer-empagliflozin-treat-adults-heart

(Original text has been abridged)

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