FDA Approves Dapagliflozin For Treatment of Chronic Kidney Disease

Officials with the FDA have approved dapagliflozin (Farxiga) for the treatment of chronic kidney disease in patients at risk of progression either with or without type 2 diabetes. According to an AstraZeneca press release, this approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years.

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that has been approved to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease (ESKD), cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk for progression. The new decision follows the Priority Review designation granted by the FDA earlier in 2021 and is based on positive results from the DAPA-CKD phase 3 trial.

Chronic kidney disease is a condition defined by decreased kidney function and is often associated with a higher risk of heart disease or stroke, or by the need for dialysis or kidney transplant. It is expected to become the fifth leading cause of mortality globally by 2040, with 37 million people estimated to currently have chronic kidney disease in the United States, according to the press release.

“Based on the unprecedented results of the DAPA-CKD trial, dapagliflozin is now the first SGLT2 inhibitor approved for the treatment of chronic kidney disease regardless of diabetes status,” said co-chair of the trial Hiddo L. Heerspink, PhD, PharmD, in the press release. “This transformational milestone provides patients and physicians with a new and effective treatment option for this often debilitating and life-threatening disease.”

The DAPA-CKD trial demonstrated that dapagliflozin, in combination with standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of ESKD, or risk of cardiovascular or renal death by 39% compared to placebo in patients with chronic kidney disease stages 2 through 4 and elevated urinary albumin excretion. The absolute risk reduction was 5.3% over the median time in study of 2.4 years, and dapagliflozin also reduced the relative risk of death from any cause by 31% compared to placebo.

Furthermore, exploratory analyses of the DECLARE-TIMI 58 phase 3 trial were conducted to determine the impact of dapagliflozin on cardiovascular outcomes and the findings support the conclusion that dapagliflozin is also likely to be effective in patients with less advanced chronic kidney disease, according to the study authors. It is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease, since it is not expected to be effective in these populations.

“Today’s approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years,” said Mene Pangalos, PhD, executive vice president of BioPharmaceuticals Research and Development at AstraZeneca, in the April 30 press release. “We’ve shown impressive efficacy for Farxiga in type 2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the US.”

REFERENCE

Farxiga approved in the US for the treatment of chronic kidney disease in patients at risk of progression with and without type 2 diabetes [news release]. AstraZeneca; April 30, 2021. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2021/farxiga-approved-in-the-us-for-the-treatment-of-chronic-kidney-disease-in-patients-at-risk-of-progression-with-and-without-type-2-diabetes-04302021.html. Accessed May 3, 2021.