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FDA fast tracks development of dapagliflozin for cardiovascular, renal death prevention in chronic kidney disease
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The FDA granted fast track designation for the SGLT2 inhibitor dapagliflozin for use in patients with or without diabetes who have chronic kidney disease to delay progression of renal failure and to prevent cardiovascular and renal death, according to a press release from AstraZeneca.
Fast track is a designation of a drug for expedited review to facilitate the development of drugs that treat a serious or life-threatening condition and fill an unmet medical need, according to the FDA.
“Chronic kidney disease affects an estimated 37 million people in the U.S. and is often associated with an increased risk of heart disease and stroke,” said Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca. “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.”
Dapagliflozin is currently indicated as an adjunct to diet and exercise to improve glycemic measures in adults with type 2 diabetes. In February, the FDA approved an expanded indication for the medication for use in patients with type 2 diabetes and moderate renal impairment with an estimated glomerular filtration rate of at least 45 mL/min/1.73m².
AstraZeneca is pursuing a clinical trial program dubbed DapaCare for developing dapagliflozin for treatment of CV, metabolic and renal diseases in patients with and without diabetes, according to the release. The program is planned to include about 30,000 participants worldwide.
As Endocrine Today previously reported, results from DECLARE-TIMI 58 demonstrated numerous benefits of the SGLT2 inhibitor for patients with type 2 diabetes, including potential for kidney disease prevention and reduction of heart failure risk. – by Jill Rollet