FDA Approves Kerendia For The Treatment Of Type 2 Diabetes
On July 9, 2021, the Food and Drug Administration (FDA) approved Kerendia—a nonsteroidal mineralocorticoid receptor antagonist—for the treatment of chronic kidney disease associated with type 2 diabetes.
The efficacy of Kerendia was evaluated at a randomized, multicenter, double-blind, placebo-controlled study in adults with chronic kidney disease (CKD) associated with type 2 diabetes. 5,674 patients enrolled in the study were randomly assigned to receive either Kerendia or a placebo.
The study compared both group’s disease progression to endpoint, acknowledged as a 40 percent reduction in kidney function, progression to kidney failure, or kidney death. The results found that 504 patients of 2,833 patients who received Kerendia had at least one of the aforementioned events compared to 600 patients out of 2,841 patients.
The study also examined cardiovascular death. 367 of 2,833 patients who received Kerendia experienced either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization compared to 420 out of 2,841 patients who received the placebo.
Documented side-effects of Kerendia include hyperkalemia (high potassium levels), hypotension (low blood pressure) and hyponatremia (low levels of sodium). Kerendia is not recommended for patients with adrenal insufficiency, a condition when the body does not produce enough hormones.
It is estimated that CKD affects 25 percent of U.S. adults with diabetes. While CKD impacts people with type 1 and type 2 diabetes, CKD prevalence was 40 percent higher in people with type 2.
According to Paul Conway, chair of policy and global affairs at the American Association of Kidney Patients, there is also a patient burden managing chronic kidney disease associated with type 2 diabetes. “The ability to keep working full time and have a career,” Conway tells Beyond Type 1. “That’s the true cost.”
CKD disproportionately impacts non-Hispanic Black adults and Hispanic adults, where CKD is 16 and 14 percent more common. “Kidney disease has an incredibly alarming, growing and disproportionate impact among minority communities and the burdens and costs are carried by patients, their families and the American taxpayer,” the American Association of Kidney Patients (AAKP) said in a press release.
The American Association of Kidney Patients applauds the recent FDA approval of Kerendia because of the substantial medical advancement and they hope it represents kidney patient consumers and their demands for treatments to slow chronic kidney disease associated with type 2 diabetes.
“I would strongly urge patients, family members and caregivers who are dealing with persons with diabetes to get as much information as they can about this treatment, and ask their doctors,” Conway says.
