Liraglutide has been approved as a weight loss agent for people who are obese and for people who are overweight and have at least one weight-related comorbidity, the Food and Drug Administration announced on Dec. 23.
The glucagon-like peptide-1 (GLP-1) receptor agonist is approved as an adjunct to a reduced calorie diet and increased physical activity in obese adults with a body mass index (BMI) of 30 kg/m2 or greater and in overweight adults with a BMI of 27 kg/m2 or greater and at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia.
Liraglutide, which is administered subcutaneously, was first approved in 2010 as a treatment for type 2 diabetes and is marketed for that indication as Victoza. Liraglutide will be marketed as Saxenda for the weight loss indication “and should not be used in combination with any other drug belonging to this class, including Victoza,” the FDA statement said. The liraglutide dose in Saxenda will be 3 mg; the dose in Victoza is 1.8 mg.
Approval for the weight loss indication was based on three studies of about 4,800 obese and overweight patients, who also received counseling about a reduced calorie diet and regular physical activity. In one study of patients who did not have diabetes, 62% of those on liraglutide and 34% of those on placebo lost at least 5% of their body weight over the course of a year. In another study of patients with type 2 diabetes, 49% of those on liraglutide and 16% of those on placebo lost at least 5% of their body weight in 1 year. Nausea, diarrhea, constipation, vomiting, and hypoglycemia were among the common adverse events associated with treatment, according to the FDA.
“Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working,” the FDA statement said. “If a patient has not lost at least 4% 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.”
Approval of Saxenda includes a Risk Evaluation and Mitigation Strategy (REMS), which outlines a plan to inform health care professionals about the risks associated with liraglutide. The drug’s label includes a boxed warning about cases of thyroid C-cell tumors associated with the drug in rat studies, with a recommendation that the drug not be used by patients with a personal or family history of medullary thyroid carcinoma (MTC) or by those with multiple endocrine neoplasia syndrome type 2. The manufacturer also is required to conduct several postmarketing studies, including a registry and at least 15 years of follow-up for MTC cases among patients treated with the drug.
Pancreatitis, gallbladder disease, and renal impairment are among the serious adverse events associated with the drug, which “can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate,” the FDA statement said.
Liraglutide is manufactured by Novo Nordisk.