FDA Approves Invokana to Treat Diabetic Kidney Disease
On Monday, September 30, 2019, the U.S. Food and Drug Administration (FDA) approved a new indication for the Janssen Pharmaceutical Companies of Johnson & Johnson’s INVOKANA (canagliflozin) to treat diabetic kidney disease (DKD). Prior to this approval, INVOKANA, an SGLT-2 inhibitor, was primarily used to reduce the risk of major cardiovascular events such as heart attacks, stroke, or death in adults with type 2 diabetes with a history of cardiovascular disease.
Based on the Phase 3 CREDENCE renal outcomes study, the only completed study on renal outcomes diabetes medication, INVOKANA is the only type 2 diabetes medication to treat diabetic kidney disease (DKD) and reduce the risk of heart failure of people with type 2 diabetes who have DKD. In CREDENCE, INVOKANA showed a 30 percent reduction in the risk of kidney failure and a 39 percent reduction in the risk of hospitalization for heart failure.
“With the approval of these new uses, INVOKANA is now the only diabetes medicine indicated to help type 2 diabetes patients reduce the risks associated with diabetic kidney disease, including hospitalization for heart failure,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “This significant advancement addresses serious unmet needs and could change the trajectory of care for the many millions of patients living with type 2 diabetes and diabetic kidney disease.”
Diabetic nephropathy, one of the complications of type 2 diabetes, disrupts the kidney’s ability to remove waste from the blood. The disruption of that function is chronicled into five stages, ranging from slightly damaged kidneys with normal function to the requiring dialysis and possibly a kidney transplant.
“Millions of type 2 diabetes (T2D) patients around the world have DKD and almost half of them aren’t even aware of it. By the time they are referred to a nephrologist, it is often too late because their disease has progressed to the point where dialysis is inevitable,” said CREDENCE study investigator George Bakris, M.D., professor of medicine and director, Comprehensive Hypertension Center, University of Chicago. “For nearly two decades, we’ve been searching for a treatment that can help us intervene earlier to slow kidney disease progression. With the approval for this new indication for INVOKANA, physicians will not only be able to help reduce the risks associated with diabetic kidney disease, but also reduce the risk of hospitalization for heart failure in patients with T2D and DKD.”
Type 2 diabetes is the leading cause of kidney disease in the United States, where one in three people with type 2 diabetes also have DKD. LaVarne A. Burton, president and CEO of the American Kidney Fund, says the approval of INVOKANA has arrived at the right time and remarks on the impact of kidney disease research: “Given the nation’s heightened focus on kidney health at the highest levels of government, this approval couldn’t have come at a better time and offers real hope for patients with type 2 diabetes and diabetic kidney disease. We know that the real battle to turn the tide on kidney disease is in early detection and slowing its progression so that patients stay healthier and fewer patients reach kidney failure. We are so grateful that advances in kidney disease research are producing treatment options that help to slow the progression of diabetic kidney disease and reduce the risk of hospitalization for heart failure.”
To learn more about the safety information and side effects of INVOKANA, click here.
