Farxiga and Chronic Kidney Disease: Trial Stopped Early for Extremely Positive Result
By Jimmy McDermott and Martin Kurian
Early trial results found that SGLT-2 inhibitor Farxiga is highly effective for preventing and treating kidney disease in people with or without type 2 diabetes
AstraZeneca announced that the DAPA-CKD trial was stopped many months early because strong data showed that Farxiga prevents chronic kidney disease (CKD) from getting worse. CKD is a common diabetes complication that can be excruciating for people with diabetes – it is major news that a medicine can be used to prevent or treat it. Farxiga is now the first SGLT-2 inhibitor drug to show important benefit in people who have CKD both with and without type 2 diabetes.
The trial, which enrolled 4,000 patients with CKD, including both people with and without type 2 diabetes, was initially expected to end in November 2020. The early stop comes after a regular assessment found the incredibly positive benefit of Farxiga.
This is a breakthrough for Farxiga and the entire class of SGLT-2 inhibitor medications. In July 2018, the CREDENCE trial also ended early. CREDENCE showed that SGLT-2 inhibitor Invokana protects against kidney disease in people with type 2 diabetes. Based on this data, The FDA approved Invokana to treat kidney disease in people with type 2 diabetes.
Farxiga will likely have an even broader approval, since the compelling effects of the drug were seen in people with and without type 2 diabetes. This is a major development for treating CDK – before Invokana, no new drugs had been approved for CKD in nearly 20 years. The emergence of another treatment option, this time expanded to more people, is an enormous win.
Given these strong results, the FDA may grant a Priority Review to allow Farxiga’s approval to happen more quickly than usual. Of course, the coronavirus pandemic may slow the FDA process.
Another SGLT-2 inhibitor, Jardiance, is currently under investigation in the EMPA-KIDNEY trial, which is expected to end in June 2022. EMPA-KIDNEY also enrolls people with and without type 2 diabetes, and even includes people with type 1 diabetes. With the very strong results, there is even more interest from scientists, clinicians, and people with diabetes to understand if the “protective” effect seen in people with type 2 with CKD and people without type 2 with CKD would also be seen in people with type 1 diabetes. diaTribe will continue to follow the research for people with diabetes. Onward!