Farxiga ( Dapagliflozin ) is a first-in-class, oral, once-daily SGLT2 inhibitor. The research for Farxiga is advancing from cardiorenal effects to prevention and organ protection as science continues to identify the underlying links between the heart, kidneys and pancreas. Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including type-2 diabetes, heart failure and chronic kidney disease ( CKD ).

For nearly a decade Farxiga has been an effective monotherapy and part of combination therapy as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes.
Following results from the landmark DECLARE-TIMI 58 phase III cardiovascular outcomes trial, it is approved in adults with type-2 diabetes to reduce the risk of hospitalisation for heart failure or cardiovascular death when added to standard of care.
Farxiga is also the first SGLT2 inhibitor approved for the treatment of heart failure with reduced ejection fraction ( HFrEF ) in adults with and without type-2 diabetes.

In August 2020, results from the DAPA-CKD phase III trial has demonstrated that Farxiga achieved unprecedented reduction in the composite risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease with and without type-2 diabetes versus placebo.
It is now the first SGLT2 inhibitor shown to significantly improve overall survival in a renal outcomes trial for this patient population and provide organ protection.

DAPA-CKD was an international, multi-centre, randomised, double-blinded phase III trial in 4,304 patients designed to evaluate the efficacy of Farxiga 10mg, compared with placebo, in patients with CKD stages 2-4 and elevated urinary albumin excretion, with and without type-2 diabetes.
Farxiga was given once daily in addition to standard of care.
The primary composite endpoint was worsening of renal function or risk of death ( defined as a composite of an eGFR decline greater than or equal to 50%, onset of end-stage kidney disease or death from cardiovascular or renal cause ). The secondary endpoints included the time to first occurrence of the renal composite ( sustained greater than or equal to 50% eGFR decline, end-stage kidney disease or renal death ), the composite of cardiovascular death or hospitalisation for heart failure, and death from any cause.
The trial was conducted in 21 countries.
Detailed results from the trial were published in The New England Journal of Medicine.

Farxiga has been approved in the US to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death and hospitalisation for heart failure in adults with chronic kidney disease at risk of progression. ( Xagena_2021 )

Source: AstraZeneca, 2021

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