FDA Approves Saxenda for Weight Management
Approved for chronic weight management in addition to reduced-calorie diet, physical activity
MONDAY, Dec. 29, 2014 (HealthDay News) -- Saxenda (liraglutide [rDNA origin] injection) has been approved by the U.S. Food and Drug Administration as a treatment option for chronic weight management, along with a reduced-calorie diet and physical activity.
The injected drug is approved for people with a body mass index (BMI) of 30 kg/m² or greater, or for those with a BMI of 27 kg/m² or greater who have at least one other weight-related condition, such as hypertension, type 2 diabetes, or dyslipidemia.
Saxenda, a glucagon-like peptide-1 receptor agonist, shouldn't be used in combination with other medications in that class. This includes the diabetes treatment Victoza, which has the same active ingredient (liraglutide) at a different dose (1.8 mg, versus 3 mg for Saxenda). Saxenda has not been evaluated to treat diabetes and should not be used for this purpose.
The medication's safety and effectiveness were evaluated in three clinical studies involving 4,800 people. In one study, some 62 percent of people who took Saxenda lost at least 5 percent of their body weight, compared with 34 percent of those who took a placebo. Saxenda's label includes a warning that thyroid tumors were observed in rats given Saxenda, although the same effect hasn't been established among people, the FDA said. Serious adverse reactions included pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. More common side effects were nausea, diarrhea, constipation, vomiting, hypoglycemia, and loss of appetite.
The drug is produced by Novo Nordisk, based in Bagsvaerd, Denmark.