Following a daylong meeting on Tuesday, an FDA expert panel voted to recommend a label update for Novo’s blockbuster diabetes drug Victoza stating the med can lower cardiovascular risks for high-risk Type 2 diabetes patients.
By a 17-2 vote, the panel concluded that an outcomes trial dubbed Leader provides significant evidence demonstrating the CV benefit for Novo’s blockbuster’s GLP-1 diabetes medication.
In that trial, Victoza reduced major adverse cardiovascular events by 13% compared to placebo. The Novo drug reduced cardiovascular deaths by 22%, any deaths by 15%, and advanced diabetic kidney disease by 22%.
Ahead of the committee’s vote, FDA reviewers published briefing documents raising no major qualms about those results. The FDA doesn’t have to follow panel recommendations, but it typically does.
While the FDA reviewers noted that two clinical studies are usually needed in order to approve a new indication, the agency can rely on one study when the trial has shown a “highly reliable and statistically strong evidence of an important clinical benefit, such as an effect on survival, and a confirmatory study would have been difficult to conduct on ethical grounds.”
Further, the reviewers pointed out that the agency approved a CV indication for Eli Lilly and Boehringer Ingelheim’s SGLT-2 drug Jardiance on a single study, Empa-Reg.
FDA committee members took two votes on Tuesday, one on whether the Leader trial establishes that use of Victoza in Type 2 diabetes patients isn’t associated with excess CV risks, and the second on whether the trial shows that Victoza reduces CV risks. The committee voted “yes” unanimously on the first question.
In its own briefing document published ahead of the meeting, Novo touted the data as supporting "a cardiovascular benefit of liraglutide in both primary and secondary cardiovascular prevention." Liraglutide is the generic name for Victoza, a GLP-1 med that was first approved in 2010.
Victoza is already approved in Type 2 diabetes in combination with diet and exercise, but the Danish drugmaker wants an addition to the label stating its med can lower the risk of major CV events in patients with high cardiovascular risks. In its document, Novo said the new indication would “provide important guidance to prescribers considering their options to treat” patients.
An important contributor for struggling Novo Nordisk, Victoza turned in $2.98 billion in sales around the world in 2016. The drug company recently had to lay off 1,000 staffers as U.S. pricing pressure took a toll on its key diabetes franchise.