The US Food & Drug Administration (FDA) has announced that empagliflozin (Jardiance) may now be marketed for heart failure patients, regardless of their ejection fraction.
The agency granted approval to Boehringer Ingelheim’s SGLT2 inhibitor for the indication of reducing the risk of cardiovascular death and hospitalisation in adults with heart failure, reports MedPage Today. This new indication makes empagliflozin the only cardiovascular prevention medication on the market with a proven track record for people with heart failure with preserved ejection fraction (HFpEF), a group that has been notoriously hard to treat.
In February 2021, sacubitril/valsartan (Entresto) became the first drug approved for prevention of cardiovascular death and hospitalisation in some HFpEF patients. However, that approval came despite the drug failing to significantly reduce heart failure hospitalisation and cardiovascular death in this group, compared with valsartan alone in the PARAGON-HF trial.
“Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Dr Norman Stockbridge, of the FDA’s Center for Drug Evaluation and Research, in a press release announcing empagliflozin’s approval.
“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.
“Coinciding with February’s annual observance of American Heart Month – a reminder for individuals to focus on cardiovascular health – this action will provide physicians with another tool to address heart disease,” he said.
FDA approved empagliflozin’s new broader heart failure indication on the basis of EMPEROR-Preserved, which was reported last August at the European Society of Cardiology annual meeting.
In nearly 6,000 people with ejection fraction greater than 40%, empagliflozin 10mg once daily reduced a composite endpoint of cardiovascular death and heart failure hospitalisation by more than 20%, relative to placebo over approximately two years, with these results mainly driven by the difference in heart failure hospitalisations.
Empagliflozin was first approved in 2014 to lower blood sugar (when used with diet and exercise) in adults with type 2 diabetes. Over the years, it also accumulated the indications for reducing risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease, as well as preventing deaths and hospitalisations in people with heart failure and reduced ejection fraction.
Potential side effects of the SGLT2 inhibitor include ketoacidosis, dehydration, serious urinary tract infections, and low blood sugar.
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