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FDA added a new indication to empagliflozin (Jardiance) for treating heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly .

The 10-mg once-daily dose of the SGLT2 inhibitor was okayed for the reduction of risk of cardiovascular death and hospitalization for heart failure based on the EMPEROR-Reduced trial reported in 2020.

In that study, empagliflozin reduced cardiovascular deaths and hospitalizations for heart failure by a relative 25% for HFrEF patients over a median 16 months, regardless of diabetes status. A key secondary endpoint demonstrated a relative 30% reduction over placebo in first or recurrent hospitalization for heart failure. The SGLT2 inhibitor can be initiated in HFrEF patients with an eGFR as low as 20 mL/min/1.73 m², according to the drugmakers.

Empagliflozin's latest indication echoes last year's FDA approval of dapagliflozin (Farxiga), another SGLT2 inhibitor, for HFrEF.

"Heart failure is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide. As the prevalence of heart failure continues to rise, the need for new treatment options is critical," said Javed Butler, MD, of University of Mississippi, Jackson, in a press release.

Empagliflozin was first approved for glucose lowering in type 2 diabetes in 2014 as an adjunct to diet and exercise.

FDA's stipulation for a subsequent post-marketing cardiovascular outcomes trial, EMPA-REG, resulted in unexpected findings of cardiovascular benefit associated with the SGLT2 inhibitor. Accordingly, empagliflozin's approval was expanded in 2016 to include for patients with diabetes and cardiovascular disease.

The mechanisms by which SGLT2 inhibitors like empagliflozin confer cardio-renal benefits remain unknown; some researchers have honed in on improvements in epicardial fat and changes in myocardial metabolism in particular.

Nevertheless, the drug development journey continues for empagliflozin, as EMPEROR-Preserved trialists teased a win in heart failure with preserved ejection fraction in results to be presented at the end of the month.

"We look forward to continuing to investigate the potential benefit of Jardiance across cardio-renal-metabolic conditions," said Mohamed Eid, MD, MPH, MHA, of Boehringer Ingelheim.

Empagliflozin is contraindicated for people with type 1 diabetes due to the increased risk of diabetic ketoacidosis in those patients. Indeed, the FDA recently a proposed indication of the drug for type 1 diabetes after an advisory panel overwhelmingly recommended against it.

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