Victoza Approved to Reduce Risk of Heart Attack, Stroke, and Heart-Related Death

By Jeemin Kwon

FDA Approves New GLP-1 Label on Victoza to show that the medicine makes hearts healthier! 

Victoza, a once-daily injectable GLP-1 agonist for type 2 diabetes, is now FDA-approved to reduce the risk of heart attack, stroke, and heart-related death. The Agency approved this new label “indication,” or use, of Victoza for people with type 2 diabetes and existing heart problems. This comes in addition to the already-approved indication for lowering A1c and helping to manage blood sugars. For emphasis, Victoza is a medicine that reduces heart disease and stroke!

Victoza’s label update to reflect its heart benefits follows a previous vote by an FDA advisory panel that met in June 2017. The advisors voted 17-2 in favor of adding the heart benefit indication based on the results from the LEADER trial, which showed that treatment with Victoza (relative to placebo) led to a:

• 22% lower risk of cardiovascular death

• 12% lower risk of non-fatal heart attacks (this result was not statistically significant, meaning it’s possible this result was due to chance)

• 11% risk reduction of non-fatal strokes (not statistically significant)

Overall, 608 people with diabetes in the Victoza group experienced one of these three negative events (13.0%) vs. 694 in the placebo group (14.9%).

And think about this – Victoza also showed a 22% risk reduction of kidney disease and a 31% risk reduction of severe hypoglycemia. These are among the best results we can remember for any diabetes drugs.

The announcement is a win for both people with diabetes and their doctors and nurses, who can now openly talk about the heart benefits of Victoza because it is in the drug’s label (if it is not “in the label,” no one can officially talk about it). Given the strong link between diabetes and heart disease, the results of LEADER are an incredibly exciting finding for long-term use of Victoza.

Of all the diabetes drugs available, only two have a heart benefit indication thus far. The first was Jardiance (SGLT-2 inhibitor, once-daily pill) which, in January 2017, was approved for an update that specifies risk reduction for heart-related death only. Victoza is now the second to gain a heart benefit indication. Other drugs currently being studied in cardiovascular outcomes trials (“CVOTs”) include SGLT-2 Invokana, GLP-1 Trulicity, SGLT-2 Farxiga, and GLP-1 Bydureon.