FDA approves Saxenda for Obesity- Novo Nordisk

The FDA has approved the New Drug Application (NDA) for Saxenda (liraglutide 3 mg), from Novo Nordisk, the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of Obesity. Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI =>30 kg/m2) or who are overweight (BMI =>27 kg/m2) with at least one weight-related comorbidity such as type 2 diabetes and cardiovascular disease.

In a recent Phase III trial, 92% (9 out of 10) of trial participants lost weight with liraglutide 3 mg treatment, in combination with diet and exercise, compared with 65% on placebo treatment. People who completed the trial (56 weeks) demonstrated significantly greater weight loss of 9.2% compared with a 3.5% reduction in the placebo group. In addition, weight loss with liraglutide 3 mg was similar across a range of baseline body mass index (BMI) subgroups in people with obesity, from overweight to Class III obesity, at 56 weeks and independent of prediabetes status at screening. A larger proportion of people treated with liraglutide 3 mg completed the trial compared with those on placebo (72% vs. 64%). All treatment groups followed a reduced-calorie diet and an increased physical activity programme.