Novo Nordisk announced that the Food and Drug Administration (FDA) has approved an update to the Saxenda (liraglutide) labeling to include new cardiovascular (CV) data from the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial

Saxenda, a glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated as an adjunct to a reduced- calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥30kg/m2) or who are overweight (BMI ≥27kg/m2) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). 

The randomized, double-blind, placebo-controlled, parallel-group study (N=9340) evaluated the time from randomization to first occurrence of major adverse CV events (MACE) (non-fatal heart attack, non-fatal stroke, CV death) in patients treated with liraglutide 1.8mg once daily or placebo. The data showed treatment with low-dose liraglutide (1.8mg) did not increase the risk of MACE in adults with type 2 diabetes and established CV disease. The total number of primary component MACE endpoints was 1302 (608 [13.0%] with liraglutide 1.8mg and 694 [14.9%] with placebo).

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“These cardiovascular data may be informative for healthcare professionals in their clinical decision-making when determining a safe, effective and comprehensive treatment approach for patients trying to lose weight and keep it off,” said Anne Phillips, MD, Senior Vice President, Clinical Development, Medical and Regulatory Affairs for Novo Nordisk. 

Saxenda is available as 6mg/mL strength solution for subcutaneous injection. It is supplied as 3mL multi-dose, prefilled pens in 3- and 5-count cartons; each individual pen delivers doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg, or 3mg. 

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