AstraZeneca's Farxiga Receives FDA Approval for Heart Failure Treatment in Adults with Reduced Ejection Fraction

On May 5 (US time), the US FDA announced the approval of AstraZeneca’s Farxiga (dapagliflozin) oral tablets for the treatment of adult patients with heart failure with reduced ejection fraction, to reduce the risk of cardiovascular death and hospitalization due to heart failure.

Heart Failure (HF) is a life-threatening condition in which the heart cannot pump enough blood to meet the body’s needs. Affecting approximately 64 million people worldwide (at least half of whom have reduced ejection fraction), HF is a chronic, progressive disease, with half of patients dying within five years of diagnosis. It is as lethal as some of the most common cancers—prostate and bladder cancer in men, and breast cancer in women. HF is the leading cause of hospitalization among adults aged 65 and older, imposing a substantial clinical and economic burden.

Dapagliflozin is a first-in-class SGLT2 inhibitor that has become well-established in the treatment of type 2 diabetes. This approval also makes dapagliflozin the first SGLT2 inhibitor to be approved for the treatment of adult patients with heart failure with reduced ejection fraction (HFrEF), regardless of whether they have diabetes.

The safety and efficacy of dapagliflozin in the treatment of heart failure were confirmed in a randomized, double-blind, placebo-controlled study. The study enrolled 4,744 patients with a mean age of 66 years, and males (77%) outnumbered females. To determine the drug’s efficacy, investigators assessed the incidence of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure. Participants were randomly assigned to receive either dapagliflozin at a once-daily dose of 10 mg or placebo (inactive treatment). After approximately 18 months, patients treated with dapagliflozin experienced a reduction in cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure compared with those receiving placebo.