Kyinsu (insulin icodec + semaglutide) recommended for approval in the EU by CHMP for treatment of type 2 diabetes mellitus – Novo Nordisk

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Kyinsu (insulin icodec + semaglutide, IcoSema) intended for treatment of type 2 diabetes mellitus.

The benefits of Kyinsu are its clinically relevant effect on glycaemic control in patients with type 2 diabetes inadequately controlled with daily basal insulin or GLP-1 receptor agonist, as shown in three multinational, multicentre, randomised, active-controlled, parallel-group phase III clinical studies. Kyinsu will be available as a 700 U/ml / 2 mg/ml solution for injection in pre-filled pens.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.