AstraZeneca announced that the Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease.
The FDA’s Fast Track program is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need. The designation was assigned to CKD patients with and without type-2 diabetes.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, 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.”
The Phase III DAPA-CKD clinical trial is currently underway to evaluate the effect of Farxiga on renal outcomes and cardiovascular mortality in patients with chronic kidney disease. The disease affects an estimated 200 million adults globally.3
CKD is associated with increased risk of therapy-resistant hypertension, chronic fluid overload, heart failure, and cardiovascular and all-cause death.
Farxiga is a pill inhibitor that can be used to improve blood sugar control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise in adults with type 2 diabetes.
Cardiovascular, Renal & Metabolism (CVRM) together form one of AstraZeneca’s three therapy areas and is a key growth driver for the company.
AstraZeneca has 1,500 employees in Delaware.
