Diabetes approval for Ozempic
The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ozempic (semaglutide), from Novo Nordisk, intended for the treatment of type 2 diabetes. Ozempic will be available as a 1.34 mg/ml solution for injection. The active substance of Ozempic is semaglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist (ATC code: A10B). Like native GLP-1, semaglutide leads to an increase in glucose-dependent insulin secretion and a reduction in glucagon release.
The benefits with Ozempic are its clinically relevant effect on glycaemic control in patients with type 2 diabetes when used in combination with other glucose-lowering medicinal products or on its own when metformin cannot be used. Ozempic has also a beneficial effect on body weight. The most common side effects are hypoglycaemia when used in certain combinations and gastrointestinal side effects such as nausea and diarrhoea.