AstraZeneca, the British-Swedish pharmaceutical and biopharmaceutical company that manufactures dapagliflozin (brand name Farxiga), has announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to dapagliflozin for adults with chronic kidney disease (CKD), whether or not they have type 2 diabetes.
Dapagliflozin is a tried-and-true medication taken by many people with type 2 diabetes. First approved by the FDA in 2014, dapagliflozin is what’s known as a sodium-glucose co-transporter 2, or SGLT2 inhibitor. It works by blocking the reabsorption of glucose by the kidney, increasing the elimination of glucose in the urine, and thereby lowering blood glucose levels.
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The FDA’s ruling was based on the results of what’s known as the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease trial, or DAPA-CKD for short. Begun in February 2017, the purpose of the study was to evaluate the possible benefits of dapagliflozin for kidney disease. The researchers enrolled 4,304 participants aged 18 and up at 392 study locations around the world, including the United States. Their average age was 61.8, two-thirds (66.9%), were men, and two-thirds (67.5%) had type 2 diabetes. The subjects were randomly divided into two groups — one group took 10 milligrams of dapagliflozin daily and the other received a placebo (inactive treatment). The subjects went for check-ups at two weeks, two months, four months and then every four months until the trial ended.
At the end of the trial period the results were impressive. The researchers reported a remarkable 39% reduction in the risk of declining kidney function, the onset of end-stage kidney disease, or kidney failure death in the dapagliflozin group as compared to the placebo group. In addition, death from all causes varied in the two groups: the subjects in the dapagliflozin half had a 31% lower risk of death from any cause than the placebo half.
One of the most intriguing aspects of the DAPA-CKD study was that one-third of the subjects didn’t have diabetes. David C. Wheeler, MD, professor of kidney medicine at University College, London, and co-chief investigator of the trial, commented, “For me, this was the most exciting part of the study…we knew that in diabetic patients, we were likely to see benefits. What was quite surprising is that we saw those same benefits in patients who had chronic kidney disease but didn’t have type 2 diabetes. And in fact, those patients seem to behave just like the diabetic patients in the trial.”
These striking results mean it’s likely that dapagliflozin, which was developed expressly for people with diabetes, can now be used to prevent kidney failure in a different group of patients. Wheeler observed the results of the trial are “going to be a little bit uncomfortable for some physicians. We’re using a drug that was designed for diabetes, and we’re going to use it in patients who don’t have diabetes. But the trial is very reassuring in terms of the efficacy in those patients, and the safety.”
According to Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, “There is a serious, unmet need for better and earlier treatment options for patients with chronic kidney disease. Following the groundbreaking DAPA-CKD results, the breakthrough therapy designation is further testament of Farxiga’s potential to slow the progression of chronic kidney disease. We look forward to working with the FDA to make Farxiga available to patients as quickly as possible.”
Want to learn more about keeping your kidneys healthy with diabetes? Read “Protecting Your Kidneys,” “Kidney Disease: Your Seven-Step Plan for Prevention” and “Ten Things to Know About Kidney Disease.”