FDA approves first new treatment in 20 years to treat diabetic kidney disease and reduce the risk of hospitalization for heart failure

By ASN Staff

The U.S. FDA has now approved INVOKANA® (canagliflozin) as the only type 2 diabetes (T2D) medicine indicated to treat diabetic kidney disease (DKD) and reduce the risk of hospitalization for heart failure in patients with T2D and DKD.  Approximately 1 in 3 patients with T2D also has DKD, which can ultimately lead to kidney failure. Once patients reach kidney failure, the average 5-year survival is less than 40%, largely due to cardiovascular-associated morbidity and mortality. This is the first new treatment option in nearly 20 years indicated to slow the progression of DKD in these patients.

The FDA decision is based off of the landmark CREDENCE study—the first and so far the only completed SGLT2-inhibitor trial studying renal outcomes as the primary endpoint in patients with DKD and T2D.events and kidney failure in this population.

“With the recently reported results of CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation), which demonstrated substantial kidney and cardiovascular benefits in patients with T2D and DKD through the use of SGLT-2 inhibitors on top of standard of care, ASN has prioritized educating the nephrology community and increasing collaboration across specialties on the use of these life-changing therapies,” an ASN press release states. In response to the recent development of new therapies for people with diabetic kidney diseases, ASN launched the Diabetic Kidney Disease Collaborative (DKD-C) on July 25, 2019.

 “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,” said LaVerne A. Burton, President and Chief Executive Officer, American Kidney Fund. “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.”

Category:
Subcategory:
Author:
ASN Staff
Body:

The U.S. FDA has now approved INVOKANA® (canagliflozin) as the only type 2 diabetes (T2D) medicine indicated to treat diabetic kidney disease (DKD) and reduce the risk of hospitalization for heart failure in patients with T2D and DKD.  Approximately 1 in 3 patients with T2D also has DKD, which can ultimately lead to kidney failure. Once patients reach kidney failure, the average 5-year survival is less than 40%, largely due to cardiovascular-associated morbidity and mortality. This is the first new treatment option in nearly 20 years indicated to slow the progression of DKD in these patients.

The FDA decision is based off of the landmark CREDENCE study—the first and so far the only completed SGLT2-inhibitor trial studying renal outcomes as the primary endpoint in patients with DKD and T2D.events and kidney failure in this population.

“With the recently reported results of CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation), which demonstrated substantial kidney and cardiovascular benefits in patients with T2D and DKD through the use of SGLT-2 inhibitors on top of standard of care, ASN has prioritized educating the nephrology community and increasing collaboration across specialties on the use of these life-changing therapies,” an ASN press release states. In response to the recent development of new therapies for people with diabetic kidney diseases, ASN launched the Diabetic Kidney Disease Collaborative (DKD-C) on July 25, 2019.

 “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,” said LaVerne A. Burton, President and Chief Executive Officer, American Kidney Fund. “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.”