AstraZeneca PLC (LON:AZN) drug Farxiga has been granted breakthrough therapy designation in the US for patients with chronic kidney disease (CKD), with and without type-2 diabetes.
In CKD, kidneys slowly stop working properly, often increasing the risk of heart disease or stroke. It affects an estimated 37mln people in the US.
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The Food and Drug Administration assigns breakthrough therapy designation to candidates addressing a significant unmet medical need and which show encouraging early clinical results.
In early trials, Farxiga on top of standard of care reduced the worsening of renal function or risk of cardiovascular or renal death by 39% while also reducing death from any cause by 31%, both compared to placebo.
The drug is already approved in the US as an addition to diet and exercise to improve glycaemic control in adults with type-2 diabetes, as well as reducing the risk of cardiovascular death and hospitalisation in adults with heart failure.