Policy & Regulation
FARXIGA Phase III DAPA-CKD Trial Will Be Stopped Early After Overwhelming Efficacy in Patients with Chronic Kidney Disease
2 April 2020 - - The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) Phase III trial for FARXIGA (dapagliflozin) in patients with chronic kidney disease will be stopped early following a recommendation from an independent Data Monitoring Committee based on its determination of overwhelming efficacy, drugmaker AstraZeneca said.

The decision to stop the trial early was made following a routine assessment of efficacy and safety which showed FARXIGA's benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial.

The primary endpoint of DAPA-CKD is a composite of worsening of renal function or death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate, onset of end stage renal disease or cardiovascular or renal death) in patients with CKD irrespective of the presence of type-2 diabetes.

The full results will be submitted for presentation at a forthcoming medical meeting and AstraZeneca will now initiate discussions with global health authorities regarding early regulatory submissions.

In August 2019, the US Food and Drug Administration granted Fast Track designation for the development of FARXIGA to delay the progression of renal failure and prevent CV and renal death in patients with CKD.

In January 2020, following positive data for the landmark Phase III DAPA-HF Trial, the US Food and Drug Administration accepted a supplemental New Drug Application and granted Priority Review for FARXIGA to reduce the risk of CV death or the worsening of Heart failure in adults with heart failure with reduced ejection fraction (HFrEF) with and without Type-2 diabetes.

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.

FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. In the US it is also approved to reduce the risk of hospitalization for HF in patients with T2D and established CV disease or multiple CV risk factors.
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