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he U.S. Food and Drug Administration today approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet andphysical activity.

The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-relatedcondition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia).

BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity andoverweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.

Obesity is a public health concern and threatens theoverall well-being of patients,” said James Smith, M.D., M.S., acting deputy director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research.“Saxenda, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides an additional treatment option for chronic weight management for people who areobese or are overweight and have at least one weight-related comorbid condition.

Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist and should not be used in combination with any otherdrug belonging to this class, including Victoza, a treatment for type 2 diabetes. Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses (3 mg and 1.8 mg,respectively). However, Saxenda is not indicated for the treatment of type 2 diabetes, as the safety and efficacy of Saxenda for the treatment of diabetes has not been established.

The safety andeffectiveness of Saxenda were evaluated in three clinical trials that included approximately 4,800 obese and overweight patients with and without significant weight-related conditions. All patients received...