Dapagliflozin is currently indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D). In the United States, it is also approved to reduce the risk of hospitalization for heart failure in patients with T2D and established cardiovascular (CV) disease or multiple CV risk factors.
AstraZeneca said Monday that a phase 3 trial for dapagliflozin (Farxiga) for 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.”
The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) trial showed benefits earlier than anticipated, the company said. The full results will be submitted for presentation at a future medical meeting. The company said it will start talks with global health authorities regarding early regulatory submissions.
Dapagliflozin is currently indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D). In the United States, it is also approved to reduce the risk of hospitalization for heart failure (HF) in patients with T2D and established cardiovascular (CV) disease or multiple CV risk factors.
“Chronic kidney disease patients have limited treatment options, particularly those without type 2 diabetes. We are very pleased the Data Monitoring Committee concluded that patients experienced overwhelming benefit,” Mene Pangalos, executive vice president of BioPharmaceuticals research and development, said in a statement, adding that the drug “has the potential to change the management of chronic kidney disease for patients around the world.”
The primary end point of DAPA-CKD is a composite of worsening of renal function or death (defined as a composite end point of ≥50% sustained decline in estimated glomerular filtration rate, onset of end-stage renal disease, or CV or renal death) in patients with CKD irrespective of the presence of T2D.
In August 2019, the FDA granted fast track designation for the development of dapagliflozin to delay the progression of renal failure and prevent CV and renal death in patients with CKD.
In January, following positive data for the phase 3 DAPA-HF Trial, the FDA accepted a supplemental New Drug Application and granted priority review for dapagliflozin to reduce the risk of CV death or the worsening of HF in adults with HF with reduced ejection fraction with and without T2D. The FDA action date for this supplemental application is scheduled for the second quarter of 2020.
Over the weekend, AstraZeneca presented more positive data in support of the approval during the 2020 American College of Cardiology / World Congress of Cardiology Virtual Experience, the online replacement for the giant gathering that was to take place in Chicago. New data show that dapaglifozin is effective in treating HF patients regardless of what other therapies they are receiving. During DAPA-HF, patients with heart failure with reduced ejection fraction (HFrEF) took a variety of different approved therapies and some were using devices, but there was a "consistent reduction," in HF.