Panel Backs Jardiance Label Expansion

By Jonathan Springston, Associate Managing Editor, AHC Media

An FDA advisory committee this week greenlighted a proposal to add important language to a key diabetes drug label, paving the way for potential final approval in a few weeks.

If approved, Jardiance, known also as empagliflozin, a drug that lowers blood sugar in patients suffering from type 2 diabetes, will be allowed to expand its label to include language noting the drug also lowers the risk of heart problems in high-risk patients.

The advisory panel made its recommendation after determining that one well-controlled trial constitutes enough evidence to allow the manufacturers of Jardiance to make such a claim.

The FDA first approved empagliflozin in 2014. Late last year, researchers published a landmark study demonstrating empagliflozin cardiovascular benefits, drawing great applause from many physicians. However, not everyone is convinced.

Writing in the January 2016 issue of Clinical Briefs in Primary Care, Louis Kuritzky, MD, raised concerns about the trial, known as “EMPA-REG.” From the issue:

“First, clinical trials with two other SGLT2 inhibitors (dapagliflozin, canagliflozin), which work by essentially comparable mechanisms, have not yet completed their cardiovascular safety trials. On the other hand, the cardiovascular outcomes from trial data thus far accrued with both of these other agents does not suggest cardiovascular risk reduction. Until FDA-mandated cardiovascular risk trials are completed with each of the agents in this class, whether individual agents might provide particular cardiovascular benefits or not will remain speculative. Second, it is difficult to reconcile how a trial that did not show a reduction in fatal or nonfatal myocardial infarction and did not show a reduction in fatal or nonfatal stroke achieved a reduction in cardiovascular mortality. Isn’t the combination of stroke + myocardial infarction the primary constituent of cardiovascular mortality?

For the time being, physicians will have to defer to the statistical wisdom of clinical trial data experts to decipher this intuitively self-contradictory result. While some physicians may want to celebrate the possible discovery of a pharmacologic treatment for T2DM associated with improved cardiovascular outcomes, I am not there yet.”

For more on the latest pharmacology news, please be sure to check out Pharmacology Watch as well as “Pharmacology Update,” a regular feature in each issue of Internal Medicine Alert. And for more on all the latest cardiology news, be sure to read Clinical Cardiology Alert.