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2020-07-30| Trials & Approvals

Multifaceted Farxiga Shows Benefit in Chronic Kidney Disease

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Chronic Kidney Disease (CKD) is a progressive and serious condition of the kidney that affects 700 million people worldwide. Along with decreased kidney function, CKD patients are also at increased risk of cardiovascular (CV) events including heart failure and premature death. The most common causes of CKD are diabetes, hypertension, and glomerulonephritis, and controlling them is of the utmost importance to reduce the risk of CKD. AstraZeneca’s Farxiga is exactly doing that.

Initially developed for treating diabetes, Farxiga is now being tested as a treatment for CKD. It is a first in class, oral, once-daily SGLT-2 inhibitor that helps in controlling blood sugar levels and provides additional benefits of weight loss and blood pressure reduction. Earlier this year, AstraZeneca got USFDA approval for the drug, which proved beneficial in reducing the risk of CV death in HF patients with reduced ejection fraction, regardless of their diabetic status.

On 28th July, AstraZeneca announced high-level results from the Phase 3 DAPA-CKD trial evaluating the efficacy of Farxiga in improving renal function and decreasing the risk of death in patients with CKD. While full data will be released at a later date, the top-line data showed a statistically significant and clinically meaningful effect of the drug on the composite primary endpoint of decreased kidney function, end-stage kidney disease, and cardiovascular death. Along with remarkable efficacy data, the drug was also found safe and well-tolerated in CKD patients. The top-line data comes months after the company stopped the trial early following the recommendation from an independent Data Monitoring Committee based on its striking efficacy data.

The co-chairs of the trial and its Executive Committee Prof. David Wheeler, University College London, and Prof. Hiddo L. Heerspink, University Medical Center Groningen, said: “The DAPA-CKD trial has shown dapagliflozin’s potential as a long-awaited new treatment option for patients with chronic kidney disease. The data will be transformative for these patients.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “DAPA-CKD is the first trial to demonstrate overwhelming efficacy, including improvement on survival, in chronic kidney disease patients both with and without type-2 diabetes. We look forward to sharing these exciting Farxiga results with the scientific community and health authorities worldwide.”

 

DAPA-CKD Trial

Farxiga was evaluated in the DAPA-CKD trial for its effectiveness in improving renal function and reducing the risk of death in patients with CKD stages 2-4 and elevated urine albumin excretion with or without diabetes. The trial was conducted in 21 countries with 4304 patients where Farxiga was given once daily in addition to standard of care. The primary endpoint is defined as a composite endpoint of greater than or equal to 50% sustained decline in estimated glomerular filtration rate, the onset of end-stage kidney disease or cardiovascular, or renal death. The secondary endpoints included the time to the first occurrence of the renal problems including renal death, the composite of CV death or heart failure, and death from any cause.

 

Upcoming Farxiga Trials

Farxiga has a robust program of clinical trials that includes more than 35 completed and ongoing Phase 2b/3 trials in more than 35,000 patients. The diabetes med is currently being investigated in DELIVER and DETERMINE trials which will evaluate its potential in reducing CV death in HF patients with either preserved ejection fraction or both reduced and preserved ejection fraction respectively. Alongside, Farxiga will also be tested in an indication-seeking registry-based randomized controlled DAPA-MI trial that includes patients who have had an acute myocardial infarction or heart attack but are not affected with diabetes.

Related Article: Spotlight: The Many Facets of AstraZeneca’s Farxiga

References
  1. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-met-all-primary-and-secondary-endpoints-in-groundbreaking-phase-iii-dapa-ckd-trial-for-the-treatment-of-patients-with-chronic-kidney-disease.html

 

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