WASHINGTON -- The FDA has approved Novo Nordisk's injectable diabetes drug liraglutide (Saxenda) for chronic weight management in adults with a body mass index (BMI) of 30 kg/m2 or over, or with a BMI of 27 kg/m2 or more and at least one weight-related medical condition, the agency announced Tuesday.
Liraglutide was previously approved under the name Victoza for treating type 2 diabetes. Doses of the two products differ: for diabetes, the approved dosage is 1.2 or 1.8 mg/day. For the weight-loss indication, the drug will be given in a 3-mg/day dose.
"Obesity is a public health concern and threatens the overall well-being of patients," James Smith, MD, acting deputy director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research, said in a statement.
"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 are obese or are overweight and have at least one weight-related comorbid condition" such as hypertension or type 2 diabetes.
An FDA advisory committee in September recommended approval of the drug by a vote of 14-1, voting that its benefits outweighed its risks. Committee members emphasized that a Risk Evaluation and Management Strategy (REMS) would be very important for assessing the risks of pancreatitis and certain cancers from taking the drug.
In its announcement, the FDA noted that "Saxenda has 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 a glucagon-like peptide-1 (GLP-1) receptor agonist and should not be used in combination with any other drug belonging to this class, the agency said.
The FDA also said it was requiring post-marketing studies for Saxenda in the following areas:
- 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
- An evaluation of the potential risk of breast cancer with Saxenda in ongoing clinical trials
"In addition, the cardiovascular safety of liraglutide is being investigated in an ongoing cardiovascular outcomes trial," the agency said.