FDA expands approval of Novo Nordisk's Victoza to include cardiovascular risk reduction claims

Novo Nordisk announced Friday that the FDA approved Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease. "This approval marks an important milestone…as cardiovascular disease is the number one cause of death in this patient population," commented Mads Krogsgaard Thomsen, chief science officer at Novo Nordisk.

In June, an FDA advisory committee voted 17-2 in favour that data from the LEADER study provide substantial evidence that the GLP-1 analogue reduces CV risk in patients with type 2 diabetes. The panel also voted 19-0 in favour of Victoza regarding the question of whether the results of the trial establish that use of the therapy in patients with type 2 diabetes is not associated with excess CV risk.

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Novo Nordisk initially submitted an application requesting an update to the label of Victoza to include data indicating a positive cardiovascular effect. The submission was supported by results from the LEADER study, in which the drug was found to cut the risk of major adverse CV events by 13 percent versus placebo, when added to standard of care. (For related analysis, see ViewPoints: Will Victoza secure a timely labelling update from the FDA?)

Victoza was initially approved in the US in 2010 for improving blood glucose control in adults with type 2 diabetes as an adjunct to diet and exercise.

Last month, the European Commission approved an update to the Victoza label, expanding its indication in EU to reflect both improving blood glucose and CV events in the treatment of type 2 diabetes.

 

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