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FDA Grants Fast Track Designation for Dapagliflozin to Prevent Kidney Failure
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Dapagliflozin’s fast track designation follows findings from last year’s DECLARE-TIMI trial, a cardiovascular outcomes trial that showed the drug’s significant impact on delaying the loss of kidney function and reducing hospitalization risk for heart failure.
AstraZeneca announced today that the FDA has granted fast track status for dapagliflozin (Farxiga), to slow the progression of kidney failure and prevent cardiovascular and renal death in patients with chronic kidney disease (CKD).
The announcement will allow regulators to expedite their review of the ongoing phase 3 DAPA-CKD study to determine its impact on renal outcomes and cardiovascular mortality in CKD patients with and without type 2 diabetes (T2D), on top of standard of care. The sodium glucose cotransporter-2 (SGLT2) inhibitor was originally approved to treat T2D, but recent studies have revealed its extensive potential beyond lowering blood glucose levels. DAPA-CKD is scheduled to be completed in 2020.
In a statement, Mene Pangalos, executive vice president, BioPharmaceuticals Research and Development for AstraZeneca, said: “Chronic kidney disease affects an estimated 37 million people in the US, and is often associated with an increased risk of heart disease and stroke. 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.”
In an interview this past June with Evidence-Based Diabetes ManagementTM (EBDM), Naeem Khan, MD, vice president of US cardiovascular and metabolic diseases at AstraZeneca, highlighted the association of T2D patients with renal complications and how the DAPA-CKD study serves to evaluate both conditions. “What we know is that the risk of developing renal impairment or CKD is high among patients with diabetes, and the SGLT2 class of medicines has generated some interesting and promising hypotheses about how they may affect the kidney,” said Khan.
Khan referred to the potential impact of SGLT2 inhibitors as he stated, “We believe these treatments could become innovative options that may address cardiorenal risks for patients with diabetes.” Providing innovative options to prevent the loss of renal function is vital as current Medicare dialysis costs are estimated at $89,000 per year. These savings would improve the quality of life for patients and benefit managed care.
Earlier this year, FDA gave dapagliflozin a new indication to allow doctors to prescribe the drug to patients with T2D and moderate renal impairment.
