On 30-Mar-2020, AstraZeneca announced that “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 (CKD) will be stopped early following a recommendation from an independent Data Monitoring Committee (DMC) based on its determination of overwhelming efficacy.”
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Reson to stop the trial:
“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 objective of the Trail:
“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 (eGFR), the onset of end-stage kidney disease (ESKD) or cardiovascular (CV) or renal death) in patients with CKD irrespective of the presence of type-2 diabetes (T2D)”
“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 (FDA) 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. Farxiga is under Priority Review with the FDA and under regulatory review at the European Medicines Agency (EMA), as well as in other regions, for the treatment of patients with heart failure (HF).”
