Breaking News – FDA Approves Invokana to Treat Kidney Disease for People with Type 2 Diabetes

The SGLT-2 inhibitor becomes the first diabetes medicine approved to treat kidney disease and reduce the risk of hospitalization for heart failure in people with type 2 diabetes and kidney disease

The FDA approved Invokana to treat kidney disease in people with type 2 diabetes. This approval addresses the need to reduce risks of kidney disease in people with type 2 diabetes. As the announcement states, type 2 diabetes is the leading cause of kidney disease in the United States. In the US, one in three people with type 2 diabetes has kidney disease. See below for more learning on kidney disease – also referred to as diabetic kidney disease (DKD). DKD is the same as CKD (chronic kidney disease) but in people with diabetes. Although people with type 1 diabetes can also have chronic kidney disease, this approval is for people with type 2 diabetes only.

The FDA also approved Invokana to reduce the risk of hospitalization for heart failure. Invokana has already been approved to reduce the risk of heart attack, stroke, and heart-related death. Read what doctors are saying about the Invokana approval below. 

The FDA made this new approval (called an “indication”) based on results from an already-famous study called CREDENCE that showed that people taking SGLT-2 inhibitor Invokana had 30% lower risk of end-stage kidney disease, of worsening kidney function, and of kidney or heart-related death. The trial tested Invokana versus placebo (a “nothing” pill) in people with type 2 diabetes and with chronic kidney disease (CKD). It was due to this exceedingly positive data that the trial was stopped early last year – it was deemed unethical to keep giving people placebo, given the clear kidney health benefit. That hardly ever happens and is a big deal.

At baseline, study participants had an average A1C of 8.3%, and all had either stage 2 or 3 CKD (click here to learn more about the stages of CKD from the world-renowned National Kidney Foundation). Importantly, they were all on blood pressure medications, meaning the kidney health benefits exist in addition to what standard-of-care CKD treatments already accomplish.

In addition to the kidney-protective benefits, results also confirmed Invokana’s heart health benefits compared to placebo:

• 31% lower risk of heart-related death or hospitalization for heart failure;

• 20% lower risk of heart attack, stroke, and heart-related death.

The new approval of Invokana to treat kidney disease and reduce the risk of hospitalization for heart failure is a huge win for the diabetes community and a massive opportunity for people with type 2 diabetes and chronic kidney disease to stay healthier. To learn more about kidney disease, check out this article.

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What do doctors think about the FDA approval of Invokana?

• “This new announcement celebrates the first drug in nearly 20 years to slow the progression of chronic kidney disease. This highlights a big shift in the future use of SGLT-2 inhibitor therapies... now there is a medication for the nephrologists (kidney doctors) to manage patients with advanced diabetic kidney disease (without worrying about glucose level), and soon it will become a drug for the cardiologists to also manage heart failure. To summarize: this is a huge day for patients with diabetes and kidney disease, and for their professional clinicians. I predict – based on this and the sum of related cardiovascular outcome and other trials – that an appropriate SGLT-2 inhibitor will soon be recommended to people with diabetes who are at high risk for, or have, cardiovascular and chronic kidney disease, to prevent or delay these conditions.” – Dr. Yehuda Handelsman (Medical Director and Principal Investigator, Metabolic Institute of America)

• “These results are transformative for the field, and further enable personalized diabetes medicine in the clinic to prevent kidney complications, improve cardiovascular outcomes, and save lives, for people with type 2 diabetes.” – Dr. Daniel Drucker (University of Toronto, Toronto, Canada)

• “The [data from the] CREDENCE study simply adds to the already strong and consistent data showing that SGLT-2 inhibitors improve outcomes for those with diabetes and associated complications. […] While it is risky to say with certainty, the profound benefit for those with T2D included in the CREDENCE study (since individuals with T1D were excluded) may well apply to those with T1D, and I believe the question must be squarely addressed considering its deep effects.” – Dr. David Harlan (UMass Memorial Health Care, Worcester, MA)