Farxiga for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes, approved by FDA


Farxiga ( Dapagliflozin ), a sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor, has been approved in the US to reduce the risk of sustained estimated glomerular filtration rate ( eGFR ) decline, end-stage kidney disease ( ESKD ), cardiovascular ( CV ) death and hospitalisation for heart failure ( hHF ) in adults with chronic kidney disease ( CKD ) at risk of progression.

The approval by the Food and Drug Administration ( FDA ) was based on positive results from the DAPA-CKD phase III trial.

The DAPA-CKD trial has demonstrated that Farxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, has reduced the relative risk of worsening of renal function, onset of end-stage kidney disease, or risk of cardiovascular or renal death by 39%, the primary composite endpoint, compared to placebo ( p less than 0.0001 ) in patients with CKD stages 2-4 and elevated urinary albumin excretion.
The absolute risk reduction ( ARR ) was 5.3% over the median time in study of 2.4 years.
Farxiga has also significantly reduced the relative risk of death from any cause by 31% ( ARR=2.1%, p=0.0035 ) compared to placebo.

Exploratory analyses of the DECLARE-TIMI 58 phase III trial, a randomised, double-blind, placebo-controlled trial, conducted to determine the effect of Farxiga on cardiovascular outcomes support the conclusion that Farxiga is also likely to be effective in patients with less advanced chronic kidney disease.

Farxiga is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease, since it is not expected to be effective in these populations.

In both trials, the safety and tolerability of Farxiga were consistent with the well-established safety profile of the medicine.

In the US, Farxiga is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes ( T2D ), and to reduce the risk of hospitalisation for heart failure in adults with T2D and established cardiovascular disease or multiple cardiovascular risk factors.
Farxiga is also indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure ( NYHA class II-IV ) with reduced ejection fraction ( HFrEF ) with and without type-2 diabetes.

Chronic kidney disease is a serious, progressive condition defined by decreased kidney function ( shown by reduced eGFR or markers of kidney damage, or both, for at least three months ) affecting 840 million people worldwide, many of them still undiagnosed.
The most common causes of chronic kidney disease are diabetes, hypertension and glomerulonephritis.
Chronic kidney disease is associated with significant patient morbidity and an increased risk of cardiovascular events, such as heart failure and premature death.
In its most severe form, known as end-stage kidney disease, kidney damage and deterioration of kidney function have progressed to the stage where dialysis or kidney transplantation are required.
The majority of patients with chronic kidney disease will die from cardiovascular causes before reaching end-stage kidney disease. ( Xagena )

Source: AstraZeneca, 2021

XagenaMedicine_2021



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