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FDA Approves Dapagliflozin for Treatment of Chronic Kidney Disease

With approval in late April, dapagliflozin becomes the first SGLT2 inhibitor to receive approval for treatment of chronic kidney disease, heart failure, and type 2 diabetes.

This article was originally published on PracticalCardiology.com.

Dapagliflozin (Farxiga) has received a historic approval from the US Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD), according to a statement from the FDA.

Almost a year to the date after receiving approval for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes, dapagliflozin now becomes the first SGLT2 inhibitor to receive approval for treatment of CKD.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, MS, deputy director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in the aforementioned statement. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Few agents have captured the attention of the masses in recent years in the same manner as dapagliflozin. With the SGLT2 inhibitor class blazing trails in heart failure and chronic kidney disease, many expected it was only a matter of time until today’s approval became reality based on data from multiple clinical trials.

In their own statement, AstraZeneca referred to the approval as "the most significant advancement in the treatment of chronic kidney disease in more than 20 years".

"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," added Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, in the statement from AstraZeneca.

Based on the results of the DAPA-CKD trial, which was originally presented at ESC 2020, the latest approval for dapagliflozin is for reducing the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. In the phase 3 trial, 4304 patients were randomized in a 1:1 ratio to either dapagliflozin or placebo.

Designed with a primary composite endpoint that included a 50% reduction in kidney function, progression to kidney failure, or cardiovascular or kidney death, results of the study indicated dapagliflozin was associated with a 39% reduction in the study’s primary endpoint. Trial investigators noted this reduction was seen in patients with and without diabetes, with reductions of 36% in patients with diabetes and 50% in patients without.

For more on the results of DAPA-CKD and how it informs the use of dapagliflozin, check out this interview from ESC 2020 with the trial's principal investigator Hiddo Heerspink, PhD, PharmD, Professor of Clinical Trials and Personalized Medicine at University Medical Center Groningen.