Dapagliflozin Gets Breakthrough Therapy Status for CKD Indication

The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to dapagliflozin (Farxiga; AstraZeneca) for patients with chronic kidney disease, with and without type 2 diabetes (T2D), to reduce the risk of kidney failure and cardiovascular (CV) or renal death.

The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early in March 2020 due to “overwhelming efficacy”. The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, to placebo on renal outcomes and CV mortality in patients with CKD (N=4304). Patients were randomized 1:1 to receive either dapagliflozin (5mg or 10mg) once daily or placebo in addition to standard of care. 

The primary end point was a composite of worsening renal function or death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate [eGFR], onset of end stage renal disease [ESRD] or CV or renal death) in patients with CKD irrespective of the presence of T2D. Secondary end points included time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESRD, and renal death), the composite of CV death or hospitalization for heart failure, and death from any cause. 

Detailed findings presented in August 2020 showed that dapagliflozin reduced the composite measure of worsening of renal function or risk of CV or renal death by 39% compared with placebo (absolute risk reduction [ARR] 5.3%; P <.0001). Additionally, the trial met all secondary end points, including significantly reducing death from any cause by 31% compared with placebo (ARR 2.1%; P =.0035). As for safety, study findings showed that patients treated with dapagliflozin experienced fewer serious side effects than those in the placebo group (29.5% vs 33.9%, respectively).

“Following the ground-breaking DAPA-CKD results, the Breakthrough Therapy designation is further testament to Farxiga’s potential to slow the progression of chronic kidney disease,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca. “We look forward to working with the FDA to make Farxiga available to patients as quickly as possible.”

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Farxiga is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with T2D. It is also indicated to reduce the risk of hospitalization for heart failure in patients with T2D and established CV disease or multiple CV risk factors; and to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure (NYHA Class II-IV) with reduced ejection fraction.

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Farxiga granted Breakthrough Therapy designation in US for chronic kidney disease. https://www.astrazeneca.com/media-centre/press-releases/2020/farxiga-granted-breakthrough-therapy-designation-in-us-for-chronic-kidney-disease.html. Accessed October 2, 2020.