FDA Approves Inclusion of LEADER Trial Data On Liraglutide Labeling
Primary endpoint of the LEADER trial was the first occurrence of composite CV outcome, including CV death, non-fatal MI, or non-fatal stroke.
Novo Nordisk announced that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of including data from the LEADER trial in the labeling for Victoza® (liraglutide, Novo Nordisk) injection.
LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results; ClinicalTrials.gov Identifier NCT01179048) was a multi-center, international, randomized, double-blind, placebo-controlled trial that evaluated long-term cardiovascular outcomes in over 9300 patients with type 2 diabetes at high risk for major cardiovascular events. The study compared Victoza up to 1.8 mg to placebo, both in addition to standard of care. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
Specifically, the Committee voted 19-0 in favor that the LEADER trial results established no excess cardiovascular risk with the use of Victoza in patients with type 2 diabetes. The Committee also voted 17-2 in favor that the results provided substantial evidence needed to establish that Victoza reduced cardiovascular risk in patients with type 2 diabetes.
Victoza, a glucagon-like peptide-1 (GLP-1) analog, is currently indicated to improve glycemic control in type 2 diabetes as adjunct to diet and exercise. It is available as 6 mg/mL strength solution for subcutaneous (SC) injection in multi-dose, pre-filled pens.
The supplemental New Drug Application (sNDA) for Victoza was submitted in October 2016. The FDA is set to take action regarding the sNDA in the third quarter of 2017.
Novo Nordisk receives positive 17-2 vote from FDA Advisory Committee that Victoza® provides substantial evidence of cardiovascular risk reduction in patients with type 2 diabetes [news release]. Plainsboro, NJ: Novo Nordisk. http://press.novonordisk-us.com/2017-06-20-Novo-Nordisk-receives-positive-17-2-vote-from-FDA-Advisory-Committee-that-Victoza-R-provides-substantial-evidence-of-cardiovascular-risk-reduction-in-patients-with-type-2-diabetes. Published June 20, 2017. Accessed June 29, 2017.