FDA Approves Novo Nordisk's Obesity Drug Saxenda

(RTTNews) - Novo Nordisk A/S (NVO) said Tuesday that the US Food and Drug Administration has approved the New Drug Application for Saxenda, the first once-daily human glucagon-like peptide-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 or who are overweight with at least one weight-related comorbidity such as type 2 diabetes and cardiovascular disease.

The safety and effectiveness of Saxenda were evaluated in three clinical trials that included about 4,800 obese and overweight patients with and without significant weight-related conditions. All patients received counseling regarding lifestyle modifications that consisted of a reduced-calorie diet and regular physical activity.

Saxenda has a boxed warning stating that tumors of the thyroid gland have been observed in rodent studies with Saxenda but that it is unknown whether Saxenda causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma, in humans. Saxenda should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2.