The European Medicines Agency (EMA) has recommended that sotagliflozin (Zynquista) be approved in the European Union as an adjunct to insulin for certain patients with type 1 diabetes mellitus.
This medicine is the second sodium-glucose co-transporter (SGLT) inhibitor to be recommended by the EMA for the treatment of type 1 diabetes.
Sotagliflozin is indicated for adults with type 1 diabetes mellitus who have failed to achieve adequate glycaemic control despite optimal insulin therapy. Patients being considered for this treatment should have a body mass index (BMI) higher than 27 kg/m2.
The EMA’s positive opinion is based on data from three phase 3 studies that included 1,853 patients and showed that sotagliflozin is associated with improved glycaemic control. The treatment was also associated with weight and blood pressure reductions and reduced variability of glucose levels.
The most common side effects are genital mycotic infections, diabetic ketoacidosis and diarrhoea.
The EMA opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State.