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AstraZeneca's Farxiga Granted Priority Review In U.S. For Treatment Of Chronic Kidney Disease

AstraZeneca Plc. (AZN.L,AZN) said Wednesday that its Farxiga has been granted priority review in the US for the treatment of new or worsening chronic kidney disease in adults with and without type-2 diabetes.

Farxiga or dapagliflozin is a first-in-class, oral, once-daily sodium-glucose co-transporter-2 inhibitor.

The Food and Drug Administration grants Priority Review to regulatory submissions for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

The company noted that the Prescription Drug User Fee Action date, the day the FDA targets for their regulatory decision, will be during the second quarter of 2021.

The acceptance of the regulatory submission by the FDA and the granting of priority review was based on clinical evidence from the DAPA- chronic kidney disease Phase III trial.

The trial showed that Farxiga reduced the risk of the composite of worsening of renal function or risk of cardiovascular or renal death by 39%, the primary endpoint, compared to placebo in patients with chronic kidney disease Stages 2-4 and elevated urinary albumin excretion.

It also significantly reduced the risk of death from any cause by 31% compared to placebo. The safety and tolerability of Farxiga were consistent with the well-established safety profile of the medicine.

In March 2020, an independent Data Monitoring Committee recommended the trial be stopped early, based on its determination of overwhelming efficacy.

In October 2020, Farxiga received Breakthrough Therapy Designation in the US for patients with chronic kidney disease with and without type-2 diabetes. In the US, Farxiga is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes.

In May 2020 Farxiga was approved in the US to reduce the risk of CV death and hospitalisation for heart failure in adults with heart failure with reduced ejection fraction with and without type-2 diabetes.

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