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FDA Approves Weight-Management Drug Saxenda (Liraglutide Injection)
The FDA has approved Saxenda (liraglutide [rDNA origin] injection, Novo Nordisk) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical 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-related condition, such as hypertension, type-2 diabetes, or dyslipidemia.
The BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the U.S. are obese.
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, including Victoza (liraglutide injection, Novo Nordisk), a treatment for type-2 diabetes. Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses (3.0 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 have not been established.
The safety and effectiveness of liraglutide injection were evaluated in three clinical trials that included approximately 4,800 obese and overweight patients with and without significant weight-related conditions. All of the patients received counseling regarding lifestyle modifications that consisted of a reduced-calorie diet and regular physical activity.
In a clinical trial of non-diabetic patients, those treated with liraglutide injection showed an average weight loss of 4.5% from baseline compared with placebo at 1 year. In this study, 62% of patients treated with liraglutide lost at least 5% of their body weight compared with 34% of patients given placebo. Results from another clinical trial that enrolled patients with type-2 diabetes showed that patients had an average weight loss of 3.7% from baseline compared with placebo at 1 year. In this study, 49% of patients treated with liraglutide lost at least 5% of their body weight compared with 16% of patients given placebo.
The labeling for Saxenda includes a boxed warning stating that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with the drug but that it is unknown whether Saxenda causes thyroid C-cell tumors, including a type of thyroid cancer called 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 (a disease in which patients have tumors in more than one gland in their bodies, which predisposes them to MTC).
Serious adverse events reported in patients treated with Saxenda include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda can also increase the heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate.
In clinical trials, the most common side effects observed in patients treated with liraglutide injection included nausea, diarrhea, constipation, vomiting, hypoglycemia, and decreased appetite.
The FDA is requiring the following post-marketing studies for Saxenda:
- 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 increases 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 FDA approved Saxenda 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 the drug.
Source: FDA; December 23, 2014.