Dapagliflozin Granted Fast Track Designation for Chronic Kidney Disease

The US Food and Drug Administration (FDA) has granted Fast Track designation to AstraZeneca’s dapagliflozin (FARXIGA), a sodium-glucose cotransporter-2 (SGLT-2) inhibitor designed to manage and improve glycemic control in adults with type 2 diabetes (T2D) mellitus.

The designation will allow the therapy to be considered sooner than standard FDA procedure for its application as a drug indicated to delay renal failure progression and prevent cardiovascular and renal death in patients with chronic kidney disease (CKD).

The Fast Track designation indicates dapagliflozin’s potential as a therapy for a serious condition currently with unmet needs.

The drug is currently being assessed under the phase 3 DAPA-CKD clinical trial, in which dapagliflozin is being administered along with standard-of-care in patients with CKD with and without T2D. It is being compared to placebo for renal outcomes and cardiovascular mortality.

Dapagliflozin’s benefit for renal outcomes is an-already regarded benefit of the SGLT-2 inhibitor based on the findings of diabetes-led cardiovascular outcome clinical trials—including the DECLARE-TIMI 58 study, in which renal outcomes were the lead secondary outcome.

In an interview with MD Magazine® while at the American Diabetes Association (ADA) 2019 Scientific Sessions, lead DECLARE-TIMI 58 author Ofri Mosenzon, MD, MSc, a professor of Internal Medicine at Hadassah Hebrew University Hospital in Israel, said the SGLT-2 inhibitor showed both significant cardiovascular-renal and renal-specific outcomes.

“Here, we were able to show the superiority and the renal protective effect of dapagliflozin in a population of patients, which are mostly what we see in our clinics every day,” Mosenzon explained. “We see patients that are mostly with preserved renal function, with preserved EGFR, and most of them are not even with albuminuria.”

Mosenzon and colleagues were able to show in a population of “considerably healthy patients,” she noted, the therapy can reduce renal insufficiency progression—and even patient progression to end-stage disease.

Dapagliflozin reaching an indication which broadens its availability to approximately 37 million CKD patients in the US would also help address the prevalence of cardiovascular disease. As AstraZeneca BioPharmaceuticals R&D executive vice president Mene Pangalos, PhD, noted, heart disease and stroke are frequently associated with chronic kidney disease.

“This Fast Track designation is an important step towards more quickly addressing unmet treatment needs in chronic kidney disease, and we will work closely with the FDA to explore the potential for FARXIGA to improve outcomes for these patients,” he said in a statement.