December 2014 -- The U.S. Food and Drug Administration approved Saxenda (liraglutide [rDNA origin] injection) 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 high cholesterol (dyslipidemia).

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, 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 and effectiveness of Saxenda were evaluated in three clinical trials that included approximately 4,800 obese and overweight patients with and without significant weight-related conditions. Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.5 percent from baseline compared to treatment with a placebo (inactive pill) at one year. In this trial, 62 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 34 percent of patients treated with placebo. Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 3.7 percent from baseline compared to treatment with placebo at one year. In this trial, 49 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 16 percent of patients treated with placebo.

Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working. If a patient has not lost at least 4 percent of baseline body weight, Saxenda should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

Serious side effects reported in patients treated with Saxenda include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda can also raise 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 Saxenda were nausea, diarrhea, constipation, vomiting, low blood sugar (hypoglycemia), and decreased appetite.

 

Source: FDA