For the first time, a diabetes drug has been approved for weight management in people without diabetes.
Liraglutide (Saxenda), a glucagon-like peptide-1 (GLP-1) receptor agonist, is now US Food and Drug Administration-approved, in combination with a reduced-calorie diet and physical activity, as a treatment option for chronic weight management in overweight/obese people.
The European Medicines Agency is also considering an application for its approval for this indication in Europe, but it is not approved by the Therapeutic Goods Administration for this indication in Australia.
Clinical studies of 1–2 years’ duration have shown liraglutide treatment enhanced weight loss and improved weight management in people without diabetes; however, concerns remain about side effects and health risks, with questions raised about limitations to study design and a lack of longer-term safety and efficacy data beyond 2 years.
For this indication, this is especially relevant because long term treatment, at a dose higher than usually recommended for glycaemic control, may be required to maintain weight.
- Liraglutide (Saxenda) has been approved for weight management in the US, in conjunction with a reduced calorie diet and physical exercise.
- Mild weight loss (4.4 kg more than for placebo) was achieved over 20 weeks, accompanied by multiple side effects, including nausea, vomiting, other GI symptoms and an increased heart rate. Rare but potentially serious health risks included hypoglycaemia, pancreatitis, gallbladder disease, renal impairment and suicidal thoughts.
- Ongoing treatment at a dose of 3.0 mg daily, higher than usually recommended for glycaemic control, is required to maintain weight loss, but the long-term safety of liraglutide at this dose is yet to be determined.
- Liraglutide (1.2 or 1.8 mg/day) is currently approved in Australia to achieve glycaemic control in type 2 diabetes, but no diabetes therapeutics have been TGA-approved at any dose for a weight loss indication.
(Source: NPS MedicineWise)