Boehringer Ingelheim and Eli Lilly announced plans to test its type 2 diabetes drug Jardiance as a treatment for patients with chronic kidney disease. The study will be conducted in both patients with and without type 2 diabetes, MPR reported.
The investigation into Jardiance as a treatment for chronic kidney disease comes from a previous trial not designed to assess the medication’s mechanisms in renal outcomes. But, kidney assessment was part of a pre-specified exploratory analysis of additional endpoints. During that trial, Jardiance was found to lower the risk for new-onset or worsening kidney disease by 39 percent in patients with type 2 diabetes and established cardiovascular disease versus a similar population of patients treated with a placebo.
Jardiance is in a class of type 2 diabetes medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. While the medication is being tested for a potential benefit to individuals with chronic kidney disease, the Food and Drug Administration (FDA) has required the SGLT2 inhibitors Invokana, Invokamet, Farxiga and Xigduo to strengthen warnings rewarding acute kidney injury risk.
Since SGLT2 inhibitors began hitting the market in 2011, the FDA has also required all drugs in the class add new warnings for ketoacidosis and serious urinary tract infections. Invokana and Invokamet were also required to add warnings regarding bone fracture and decreased bone mineral density. And, more recently, the FDA required new amputation risk warnings be added to the safety labels of Invokana and Invokamet.
Invokana and Invokamet are manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals. The company faces a growing number of lawsuits over failing to warn doctors and patients of Invokana side effects.