Farxiga Found to Have “Overwhelming” Benefit for Kidney Disease

Pharmaceutical company AstraZeneca announced last week[1] that it was halting an ongoing trial of its drug Farxiga (dapagliflozin) for the treatment of chronic kidney disease (CKD), due to an “overwhelming” benefit seen in preliminary results.

Farxiga is a type of drug called an SGLT2 inhibitor[2], and it’s currently used to treat type 2 diabetes[3]. It works by stopping reabsorption of glucose in your kidneys, which leads to more glucose being excreted in urine. The current trial, called DAPA-CKD (Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease)[4], was designed to look at whether the drug could slow the progression of chronic kidney disease — regardless of whether someone also has diabetes. Diabetes is the leading cause of CKD, according to the National Institute of Diabetes and Digestive and Kidney Diseases[5].

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As noted in AstraZeneca’s press release, researchers were evaluating the effectiveness of Farxiga in people with CKD by looking at its effect on worsening of kidney function. The “primary endpoint” of the study was defined as when a participant had at least a 50% sustained decline in estimated glomerular filtration rate (eGFR, a measure of kidney function), developed end-stage kidney disease (if they didn’t have it already), or died from cardiovascular causes or kidney disease. Researchers were interested in whether taking Farxiga prevented any of these outcomes in a significant number of participants.

The decision to stop the study was made in a routine review of its progress by an independent data monitoring committee. Typically, such a decision is made only when a drug is found to be overwhelmingly beneficial or dangerous. AstraZeneca said that it would announce the actual results of the study at an upcoming medical conference, and that it would immediately start conversations with regulatory agencies around the world about submitting its data to have Farxiga approved quickly to treat CKD.

The U.S. Food and Drug Administration (FDA) already granted AstraZeneca “Fast Track” status for developing Farxiga[7] as a treatment for CKD in August 2019. This designation is designed to “expedite the review of drugs to treat serious conditions and fill an unmet medical need,” according to the FDA[8].

“Chronic kidney disease patients have limited treatment options, particularly those without type 2 diabetes,” said Mene Pangalos, executive vice president for BioPharmaceuticals R&D at AstraZeneca, in the press release. “Farxiga has the potential to change the management of chronic kidney disease for patients around the world.”

Want to learn more about keeping your kidneys healthy with diabetes? Read “Protecting Your Kidneys,”[9] “Kidney Disease: Your Seven-Step Plan for Prevention”[10] and “Ten Things to Know About Kidney Disease.”[11]

  1. announced last week: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-phase-iii-dapa-ckd-trial-will-be-stopped-early-after-overwhelming-efficacy-in-patients-with-chronic-kidney-disease.html
  2. SGLT2 inhibitor: https://www.diabetesselfmanagement.com/blog/diabetes-medicine-sglt2-inhibitors/
  3. type 2 diabetes: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-2-diabetes/
  4. DAPA-CKD (Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease): https://pubmed.ncbi.nlm.nih.gov/32030417/
  5. according to the National Institute of Diabetes and Digestive and Kidney Diseases: https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-problems/diabetic-kidney-disease
  6. sign up for our free newsletter: https://www.diabetesselfmanagement.com/newsletter/
  7. AstraZeneca “Fast Track” status for developing Farxiga: https://www.astrazeneca.com/media-centre/press-releases/2019/fda-grants-fast-track-designation-for-farxiga-in-chronic-kidney-disease-27082019.html
  8. according to the FDA: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
  9. “Protecting Your Kidneys,”: https://www.diabetesselfmanagement.com/managing-diabetes/complications-prevention/protecting-your-kidneys/
  10. “Kidney Disease: Your Seven-Step Plan for Prevention”: https://www.diabetesselfmanagement.com/blog/kidney-disease-seven-step-plan-prevention/
  11. “Ten Things to Know About Kidney Disease.”: https://www.diabetesselfmanagement.com/blog/ten-things-know-kidney-disease/

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