Boehringer Ingelheim and Eli Lilly’s Jardiance Approved by FDA to Treat Adults With HFrEF

August 18, 2021—Boehringer Ingelheim and Eli Lilly and Company announced that Jardiance (empagliflozin) 10 mg has been approved by the FDA to reduce the risk of cardiovascular death plus hospitalization for heart failure (HF) in adults with HF with reduced ejection fraction (HFrEF).

Jardiance can be initiated in adults with HFrEF with an estimated glomerular filtration rate (eGFR) as low as 20 mL/min/1.73 m². This FDA approval of Jardiance in patients with HFrEF in the United States, comes after authorization for use in the European Union that was received in June, the announcement noted.

“HF is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide,” commented Javed Butler, MD, in the company’s press release. “As the prevalence of HF continues to rise, the need for new treatment options is critical. Empagliflozin is a vital new therapeutic option to reduce the risk of cardiovascular death and hospitalization for adults with HFrEF.” Dr. Butler is Chairman, Department of Medicine, University of Mississippi in Jackson, Mississippi.

The companies advised that Jardiance is not for patients with type 1 diabetes, in whom it may increase the risk of diabetic ketoacidosis. It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR of < 30 mL/min/1.73 m² as it is likely to be ineffective in this setting based upon its mechanism of action. Additionally, Jardiance is contraindicated in patients with hypersensitivity to empagliflozin or any of the excipients of Jardiance as reactions such as angioedema have occurred and is contraindicated in patients on dialysis.

According to the companies, this approval for Jardiance is based on results from the international, randomized, double–blind EMPEROR-Reduced phase III trial. The trial investigated the effect of adding Jardiance 10 mg versus placebo to standard of care in a broad range of 3,730 adults with and without type 2 diabetes who had HF (functional class II, III or IV) and a left ventricular ejection fraction ≤ 40%.

In the EMPEROR-Reduced trial, 1,863 patients were randomized to once-daily Jardiance 10 mg and 1,876 patients were randomized to placebo, in addition to treatment with guideline-directed HF therapy. Median follow-up time was 16 months. The composite primary endpoint was defined as time to first event of cardiovascular death or hospitalization for HF.

Jardiance significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for HF by 25% (5.3% absolute risk reduction; 0.75 hazard ratio [HR]; 95% CI, 0.65-0.86) versus placebo. These results were seen regardless of background HF standard of care treatments.

A key secondary endpoint analysis from EMPEROR-Reduced demonstrated that Jardiance helped keep patients out of the hospital by significantly reducing the relative risk of first and recurrent hospitalization for HF by 30% (388 events for Jardiance vs 553 for placebo; 0.70 HR; 95% CI, 0.58-0.85). The safety profile was consistent with the well-established safety profile of Jardiance, noted the companies' announcement.