FDA Grants AstraZeneca’s Dapagliflozin Breakthrough Therapy Designation for CKD

October 2, 2020

The FDA has granted dapagliflozin (Farxiga) breakthrough therapy designation for patients with chronic kidney disease.

The US Food and Drug Administration granted dapagliflozin (Farxiga; AstraZeneca) breakthrough therapy designation (BTD) in the US for patients with chronic kidney disease (CKD), with and without type 2 diabetes (T2D).

According to an October 2, 2020 press release from AstraZeneca, the BTD was based on results from the DAPA-CKD clinical trial that showed dapagliflozin, on top of standard of care, decreased the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% vs placebo (absolute risk reduction [ARR]=5.3%, p<.0001) in patients with CKD.

The study also found that dapagliflozin significantly reduced death from any cause by 31% (ARR=2.1%, p=0.0035) vs placebo.

“There is a serious, unmet need for better and earlier treatment options for patients with chronic kidney disease. 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, in the company’s press release.

Dapagliflozin is already approved in the US as an adjunct to diet and exercise to improve glycemic control in adults with T2D and to reduce the risk of hospitalization for heart failure in T2D patients with established CV disease or multiple CV risk factors.

It is also approved to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction with or without T2D; it is not indicated to reduce the worsening of renal function or death in patients with CKD.

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