New GLP-1 agonist recommended for type 2 diabetes
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for the long-acting glucagon-like peptide-1 (GLP-1) agonist semaglutide (Ozempic) for the treatment of type 2 diabetes.
The CHMP recommends that semaglutide is licensed for use in adult patients with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise, either as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other diabetes medicines.
GLP-1 agonists lower blood glucose by increasing glucose-dependent insulin secretion and reducing glucagon secretion. If marketing authorisation is granted by the European Commission, semaglutide will be the sixth GLP-1 agonist on the market, joining exenatide, albiglutide, dulaglutide, liraglutide and lixisenatide.
Semaglutide is administered by once-weekly subcutaneous injection using a pre-filled pen. Its efficacy has been demonstrated in the SUSTAIN programme, comprising eight phase 3a clinical trials and including over 8000 patients with type 2 diabetes. A post-hoc analysis of the SUSTAIN 1–5 trials showed that significantly more patients achieved clinically meaningful reductions in both HbA1c (≥1% reduction) and body weight (>5% weight loss) with semaglutide than with placebo, sitagliptin, extended-release exenatide and insulin glargine 100 units/ml (25–56% vs 2–13%; p<0.0001).
The most common adverse effects are hypoglycaemia (when used in combination with other antidiabetic agents) and gastrointestinal effects, including nausea, vomiting and diarrhoea. Semaglutide has been added to the medullary thyroid carcinoma registry, as is required for all long-acting GLP-1 agonists. Company Novo Nordisk has also agreed to conduct post-approval safety trials, including a long-term diabetic retinopathy study.