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FDA approves GLP-1 receptor agonist liraglutide injection Saxenda for weight management

Wednesday, January 14 2015 | Comments
Evidence Grade 0 What's This?
The Food and Drug Administration approved a 3 mg injection of the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide for chronic weight management in addition to reduced calorie diet and exercise in obese (body mass index [BMI] >=30 kg/m2) or overweight (BMI >=27 kg/m2) adults with <=1 weight-related comorbidity, such as type 2 diabetes or cardiovascular disease.

Liraglutide 1.8 mg injection, marketed by Novo Nordisk A/S as Victoza, is indicated for the treatment of type 2 diabetes.

The new dose of liraglutide will be marketed as Saxenda for the weight management indication. Importantly, Saxenda is not indicated for treating diabetes, as its safety and efficacy in this patient population has not been established.

Saxenda should not be given to people already taking a GLP-1 receptor agonist. Treatment should be evaluated at 16 weeks. If the patient has not lost at least 4% of body weight by 16 weeks, treatment should be discontinued, as it is unlikely to succeed.

The approval was based on 3 clinical trials that included approximately 4,800 obese and overweight patients with and without significant weight-related conditions.

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

Saxenda is approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with Saxenda. Postmarketing requirements imposed by the FDA include: clinical trials to evaluate dosing, safety, and efficacy in pediatric patients; a study to assess potential effects on growth, sexual maturation, and central nervous system development and function in immature rats; an MTC case registry of at least 15 years' duration to identify any increase in MTC incidence related to Saxenda; and an evaluation of the potential risk of breast cancer with Saxenda in ongoing clinical trials.

The cardiovascular safety of liraglutide is being investigated in an ongoing cardiovascular outcomes trial.

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