Astrazeneca Share News (AZN)

(Sharecast News) - AstraZeneca announced on Wednesday that 'Farxiga', or dapagliflozin, has been granted Priority Review status in the United States for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).
The FTSE 100 pharmaceuticals giant explained that the Food and Drug Administration (FDA) grants Priority Review status to regulatory submissions for medicines that offered "significant advances" over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

It said the Prescription Drug User Fee Action date - the day the FDA targets for their regulatory decision - would be during the second quarter of 2021.

CKD, a condition defined by decreased kidney function, was often associated with a heightened risk of heart disease or stroke, or the need for dialysis or kidney transplant, AstraZeneca said.

The disease was expected to become the world's fifth leading cause of mortality by 2040, and currently in the US, 37 million people were estimated to have CKD.

AstraZeneca said the acceptance of the regulatory submission by the FDA and the granting of Priority Review was based on clinical evidence from the 'DAPA-CKD' phase 3 trial.

The trial showed that Farxiga, on top of standard-of-care consisting of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), 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 CKD stages 2-4 and elevated urinary albumin excretion.

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

In March, an independent data monitoring committee recommended the trial be stopped early, based on its determination of overwhelming efficacy.

Following that, in October Farxiga received 'Breakthrough Therapy Designation' in the US for patients with CKD with and without T2D.

In the US, Farxiga was indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D.

Last May, Farxiga was approved in the US to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure with reduced ejection fraction, with and without T2D.

"This decision brings us a step closer to delivering this new treatment option for the millions of patients living with chronic kidney disease in the US," said executive vice-president of biopharmaceuticals research and development, Mene Pangalos.

"Farxiga has the potential to be a truly transformational medicine across a breadth of diseases, including type-2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease."

At 0822 GMT, shares in AstraZeneca were down 0.43% at 7,407p.