Big News! FDA Votes to Show Heart Benefits on GLP-1 Agonist Victoza's Label
By Ann Carracher and Kelly Close
An FDA advisory panel voted 17-2 to expand the drug label for type 2 diabetes drug Victoza to reflect a 13% reduction in overall heart risk and 22% reduction in heart-related death, as shown in the LEADER trial
Yesterday, a US FDA advisory panel voted 17-2 in favor of updating the drug label for Victoza (a once-daily injectable GLP-1 agonist) to reflect its demonstrated heart benefits. Specifically, the LEADER trial had previously shown that treatment with Victoza plus regular diabetes care resulted in a 13% reduction in overall heart risk and a 22% reduction in heart-related death. Risk for kidney disease and hypoglycemia were also significantly reduced with Victoza treatment.
Advisory panel members overwhelming said that the trial’s strong reduction in both heart-related and overall death was convincing. That wasn’t really the controversial or truly meaningful part, but that was good to see – so, with a 19-0 “yes” vote, they agreed that Victoza did not increase heart-related risks. Much more notably, by a resounding 17-2 “yes” margin, the panel emphasized that Victoza significantly reduced heart-related risks in people with type 2 diabetes and a history of heart problems. While some members of the panel expressed that they were not sure how much of the good news from Victoza applied to every different group in the study (for example, those from various geographies), they agreed as a group that for now, what can be said is that Victoza benefits those at “high risk” for heart problems.
Going into the panel, the FDA expressed several safety concerns with Victoza – namely, concerns related to thyroid and pancreatic cancer and inflammation. However, the panel of experts, which included many healthcare providers, ultimately agreed that treatment with Victoza currently seems to be safe. In fact, very highly regarded panel member Dr. Judy Fradkin, head of diabetes at the NIH, said she actually felt that there were too many warnings on cancer on the Victoza label, and she felt this might be preventing some who would benefit from taking Victoza.
Now it’s up to the FDA regulators to move forward on updating Victoza’s label – though not always the case, history indicates there's a strong chance that the FDA will agree with the panel's vote. A decision is expected toward the end of 2017 by the FDA in the US, and a decision by the EMA is expected any day.
Overall, Tuesday’s vote is an exciting development for the diabetes community, especially for people with type 2 diabetes and a history of heart problems – those most likely to benefit. As endocrinologist Dr. David Robbins (University of Kansas, Kansas City) noted during the FDA panel, diabetes treatment is fortunately moving toward more than just lowering A1c and is all about preventing heart problems and other risks for people with diabetes – this is excellent news for people with diabetes, their families, society, insurance providers, and overall public health.