FDA approves dapagliflozin (Farxiga) for heart failure in patients aged 10 years and older

On 9 October 2026, FDA approved a supplemental indication for dapagliflozin (Farxiga; AstraZeneca) ↗ to reduce the risk of cardiovascular death and worsening heart failure in paediatric patients aged 10 years and older with heart failure with reduced ejection fraction (HFrEF). This is the first SGLT2 inhibitor approved for heart failure in the paediatric population. The approval adds a new paediatric weight-based dosing section (10 mg OD for ≥40 kg; 5 mg OD for 20–<40 kg) to the existing adult Farxiga label.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors reduce myocardial stress via multiple mechanisms beyond glucose lowering: (1) natriuresis and osmotic diuresis — reducing preload and afterload; (2) haematocrit rise — improving tissue oxygen delivery; (3) ketone body utilisation — providing an alternative cardiac fuel (the "thrifty substrate" hypothesis); (4) direct cardiomyocyte effects on ion transport (NHE-1 inhibition, reducing intracellular Na+/Ca2+ overload). These mechanisms are largely glucose-independent, explaining efficacy in non-diabetic HF patients. See ACC/AHA Heart Failure Guidelines ↗.

The approval was supported by the DAPA-HF-PEDS trial — a randomised, double-blind, placebo-controlled trial in 407 paediatric patients (aged 10–17) with HFrEF (LVEF ≤40%). Dapagliflozin reduced the primary composite endpoint of CV death, hospitalisation for heart failure, or urgent heart failure visit by 32% vs placebo (HR 0.68, 95% CI 0.52–0.89, p=0.004). Glycaemic effects were minimal in the predominantly non-diabetic cohort. Safety findings consistent with adult trials — no new paediatric-specific safety signals identified. Consistent with adult evidence from DAPA-HF (McMurray 2019) ↗.

Paediatric HFrEF is predominantly caused by dilated cardiomyopathy, congenital heart disease, and myocarditis — differing aetiology from adult HFrEF. Before this approval, the pharmacological armamentarium was largely off-label extrapolation from adult data. Prescribing considerations: (1) avoid in patients with eGFR <25 mL/min/1.73m² (reduced efficacy and tolerability); (2) hold before major surgery or prolonged fasting (DKA risk, including euglycaemic DKA in non-diabetic patients); (3) genital mycotic infections and UTIs are class effects — counsel patients and caregivers; (4) consider renal dose considerations in adolescents with cardiac renal syndrome. See paediatric pharmacology guide for developmental PK context.