The Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin; AstraZeneca) to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).

The approval was based on data from the landmark phase 3, randomized, double-blind, placebo-controlled DAPA-HF trial that evaluated the efficacy of Farxiga plus standard of care therapy for the prevention of CV death or reduction of HF events (N=4744). At baseline, 94% of patients were treated with angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers or angiotensin receptor-neprilysin inhibitor (including sacubitril/valsartan 11%), 96% with beta blockers, 71% with mineralocorticoid receptor antagonists, 93% with diuretics, and 26% had an implantable device.

Patients were randomized to receive either Farxiga 10mg once daily or placebo. The primary composite outcome was the time to first occurrence of CV death or worsening HF (hospitalization or an urgent visit resulting in intravenous therapy for HF).

Results demonstrated that Farxiga plus standard of care reduced the risk of CV death or worsening HF by 26% compared with placebo (primary composite outcome occurred in 386 patients treated with Farxiga over a median of 18.2 months vs 502 patients in the placebo arm [hazard ratio (HR) 0.74; 95% CI, 0.65-0.85; P <.0001]). All 3 components of the primary composite end point individually contributed to the treatment effect.

Additionally, Farxiga reduced the total number of hospitalizations for HF (first and recurrent) events and CV death, with 567 and 742 total events in the Farxiga-treated vs placebo group (rate ratio 0.75; 95% CI, 0.65-0.88; P =.0002). Findings were consistent in patients with or without diabetes.

No new adverse reactions were identified in the DAPA-HF study. The most common adverse reactions associated with Farxiga treatment include female genital mycotic infections, nasopharyngitis, and urinary tract infections.

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“Heart failure is a serious health condition that contributes to 1 in 8 deaths in the US and impacts nearly 6.5 million Americans,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization.”

Farxiga, a sodium-glucose cotransporter (SGLT2) inhibitor, is already indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; and to reduce the risk of hospitalization for HF in adults with type 2 diabetes mellitus and established CV disease or multiple CV risk factors.

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