FARXIGA Granted Priority Review in the US for the Treatment of Patients With Chronic Kidney Disease

Rhea-AI Summary

AstraZeneca’s FARXIGA (dapagliflozin) has received Priority Review status from the FDA for treating chronic kidney disease (CKD) in adults, with or without type 2 diabetes. This review reflects the potential of FARXIGA to significantly improve patient outcomes. The FDA aims for a decision by Q2 2021. In clinical trials, FARXIGA reduced the risk of worsening renal function or cardiovascular death by 39% and overall mortality by 31%. This treatment, already indicated for diabetes and heart failure, has shown promising efficacy according to the DAPA-CKD Phase III trial.

Positive

• FDA granted Priority Review for FARXIGA for CKD, indicating potential for significant patient benefit.
• Clinical trials showed FARXIGA reduced risk of worsening renal function or cardiovascular death by 39%.
• The treatment also decreased all-cause mortality by 31%, indicating strong efficacy.

Negative

• None.

AstraZeneca’s FARXIGA (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).

The Food and Drug Administration (FDA) 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 Prescription Drug User Fee Action date, the day the FDA targets for their regulatory decision, will be during the second quarter of 2021.

CKD, a condition defined by decreased kidney function, is often associated with a heightened risk of heart disease or stroke, or the need for dialysis or kidney transplant. CKD is expected to become the world’s fifth leading cause of mortality by 2040. Currently in the US, 37 million people are estimated to have CKD.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “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. 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.”

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 III trial showing 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 (CV) or renal death by 39%, the primary endpoint, compared to placebo (absolute risk reduction [ARR] 5.3%, p<0.0001) 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% (ARR 2.1%, p=0.0035) 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. Detailed results from the DAPA-CKD trial were shared in August 2020 and published in The New England Journal of Medicine.

In October 2020, FARXIGA received Breakthrough Therapy Designation in the US for patients with CKD with and without T2D. In the US, FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D and to reduce the risk of hospitalization for heart failure in patients with T2D and established CV disease or multiple CV risk factors. In May 2020 FARXIGA was approved in the US to reduce the risk of CV death and hospitalization for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D. FARXIGA is not indicated to reduce the worsening of renal function or death in patients with CKD.

INDICATIONS AND LIMITATIONS OF USE for FARXIGA^® (dapagliflozin)

FARXIGA is indicated:

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors
• to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction

FARXIGA is not recommended for patients with type 1 diabet

FAQ

What is the significance of the FDA's Priority Review for AZN's FARXIGA?

The Priority Review indicates that FARXIGA may offer significant advantages over current treatments for chronic kidney disease, potentially improving patient outcomes.

What are the trial results for FARXIGA in chronic kidney disease?

FARXIGA reduced the risk of worsening renal function or cardiovascular death by 39% and all-cause mortality by 31% in the DAPA-CKD trial.

When is the FDA's decision date for FARXIGA's CKD treatment?

The FDA targets a decision for FARXIGA's CKD indication during the second quarter of 2021.

How many people in the US are affected by chronic kidney disease?

Approximately 37 million people in the US are estimated to have chronic kidney disease.

What existing indications does FARXIGA have?

FARXIGA is indicated for improving glycemic control in type 2 diabetes, and reducing risks of hospitalization for heart failure and cardiovascular death.