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EMPA-REG, the FDA, and the Future of SGLT-2s

Jun 18, 2016

With so much breaking news surrounding SGLT-2 Inhibitors at ADA, what conclusions can we draw? Viewpoints from our guest editorialist David Kliff, and DIC advisory board member Dr. George Bakris.

david_kliffDavid Kliff, guest editor (Publisher, Diabetic Investor)Last Tuesday, during the ADA Scientific Sessions, the FDA issued stronger warnings for two SGLT-2s, Invokana and Farxiga:

“FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).  Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.”

This follows news from Lilly as their SGLT-2 Jardiance, which was not included in this warning, cut the risk for new-onset or worsening kidney disease by 39%.

The general feeling in the diabetes medical community is that the cardiovascular benefits seen with Jardiance will be replicated by fellow SGLT-2 inhibitors Invokana and Farxiga, that this is a class effect. However, neither Johnson and Johnson (Invokana) or AstraZeneca (Farxiga) can support this belief with hard data yet.

With the FDA warning combined with the Lilly data on kidney disease, will physicians begin to favor Jardiance over other drugs in this class when prescribing? Another major question is the impact on payors. To date, Invokana has had preferential treatment with payors. While Lilly has yet to see increased sales of Jardiance since the EMPA-REG results became public, it’s possible that may change with the news of kidney disease benefits, and payors may see reason to favor Jardiance.

Payors and physicians are a risk adverse bunch and given the option they will avoid risk when they can. Even if the cardiovascular data from Invokana and Farxiga turns out to be better than that seen with Jardiance, there is still the issue of acute kidney injury. It’s possible payors and physicians may not wait for this cardiovascular data and will begin making changes based on the increased kidney risk.

george_bakrisComment from Dr. George Bakris, MD, FASN, FASH, FAHA, Professor of Medicine, Director, ASH Comprehensive Hypertension Center and on Advisory Board for Diabetes in Control and for the National Kidney Foundation:

“I’m sure the FDA did this because they are overly concerned about safety of these new drugs.  If you use SGLT2s with diuretics and with ACEi or ARBs especially in older people not drinking a lot of fluid this is what will happen-I don’t use them with diuretics and advise people to drink water and have never had a problem.”



FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)