The FDA today approved liraglutide (rDNA origin) injection (Saxenda) as a treatment option for chronic weight management alongside a reduced-calorie diet and physical activity.
 
The drug is approved for use in obese adults with a body mass index (BMI) of 30 or greater or overweight adults with a BMI of 27 or greater who have at least 1 weight-related condition, such as hypertension, type 2 diabetes, or high cholesterol.
 
“Obesity is a public health concern and threatens the overall well-being of patients,” said James Smith, MD, MS, acting deputy director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research, in a press release. “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.”
 
Saxenda’s safety and effectiveness were evaluated in 3 clinical trials that included approximately 4800 obese and overweight patients with and without significant weight-related conditions. All patients were counseled about lifestyle modifications such a reduced-calorie diet and regular physical activity.
 
Results from a clinical trial that enrolled those without diabetes showed that patients had an average weight loss of 4.5% from baseline compared to a placebo group after 1 year. In this trial, 62% of patients treated with Saxenda lost at least 5% of their body weight compared with 34% of patients in the placebo group.
 
Results from another clinical trial that enrolled those with type 2 diabetes showed that patients had an average weight loss of 3.7 % from baseline compared to a placebo group after 1 year. In this trial, 49% of patients treated with Saxenda lost at least 5% of their body weight compared with 16% of patients in the placebo group.
 
The most common side effects observed in patients treated with Saxenda during the clinical trials were nausea, diarrhea, constipation, vomiting, hypoglycemia, and decreased appetite. Serious side effects reported in patients treated with Saxenda included pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda can also increase heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate.
 
Saxenda’s boxed warning states that while thyroid C-cell tumors have been observed in rodent studies with Saxenda, 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.
 
Saxenda is a glucagon-like peptide-1 receptor agonist and should not be used in combination with any other drug belonging to this class, including Victoza, a treatment for type 2 diabetes; while Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses, 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 cardiovascular safety of liraglutide is being investigated in an ongoing cardiovascular outcomes trial.
 
Patients using Saxenda should be evaluated after 16 weeks to determine the effectiveness of the treatment. If a patient has not lost at least 4% of baseline body weight by this point, Saxenda should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
 
The FDA is requiring the following post-marketing studies for Saxenda:
  • Clinical trials to evaluate dosing, safety, and efficacy in pediatric patients;
  • 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 FDA approved Saxenda with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risks associated with Saxenda.