FDA Extends Dapagliflozin Indication Across LVEF Spectrum

The US Food and Drug Administration has broadened the indications for dapagliflozin (Farxiga; AstraZeneca) to reduce the risk of cardiovascular death, unplanned hospitalization for heart failure, and urgent heart failure visits across the spectrum of ejection fraction.

The decision was based on the positive results from the DELIVER trial, presented at last year’s European Society of Cardiology Congress, as well as a range of other meta-analyses and studies looking at this particular sodium glucose cotransporter 2 (SGLT2) inhibitor alone and in combination with empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) released around the same time.

Dapagliflozin was previously approved for the treatment of patients with type 2 diabetes, heart failure with reduced ejection fraction (HFrEF), and chronic kidney disease (CKD) in the US, the European Union, China, and Japan. Today’s decision to extend the indication across the LVEF range, including heart failure with mid-range ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF), follows similar decisions in the EU, United Kingdom, and elsewhere.

A similar labelling extension for empagliflozin—on the basis of EMPEROR-Preserved—was announced in February of 2022.

A press release announcing today’s news notes that roughly half of all heart failure patients have either HFmrEF or HFpEF, not just putting them “at greater risk of death and hospitalizations” but also causing them to “experience an especially high burden of symptoms and physical limitations, and a poor quality of life.”