Sanofi has reported that the European Commission has authorized the commercialization of 'Soliqua', the combination of fixed basal insulin ratio (Glargina 100 units/ml) and the agonist of the LP-1 receptor receptor lixisenatid, adjustable, administered once a day, for the treatment of type 2 diabetes in adults.
"It is a new innovative therapeutic combination that can meet the non -covered needs of people living with type 2 diabetes in Europe. The approval of 'Soliqua' represents the success of Sanofi's effort of scientists to combine two injectable treatments in aUnique and adjustable dose.
Sanofi has a long history in the care of people with diabetes, and we believe that 'Soliqua' will make it easier for patients with diabetes with inappropriate control to be able to achieve their treatment goals, "said the president of R&D DSanofi Global, Elias Zerhouni.
The decision to authorize the commercialization of 'Soliqua' in Europe is based on the data obtained from two studies in phase III, 'Lixilan-O' and 'Lixilan-L', which included more than 1,900 patients with type 2 diabetesof all the world to evaluate the effectiveness and safety of the combination of fixed ratio in populations of patients who had insufficient control with oral antidiabetics (ADO), in the study 'Lixilan-O', or with basal insulin, in the ''Lixilan-l '.
Specifically, 'Soliqua' demonstrated a decrease in statistically higher blood glucose (HBA1C) against lixisenatid and insulin Glargina 100 units/ml in 'Lixilan-O', and in front of insulin Glargina 100 units/ml in 'Lixilan-l'.
'Soliqua' will be marketed in two preloaded feathers 'Solostar', which offer different dosing options that could help meet individual insulin needs of market and patients.The difference between the feathers is based on the dose interval and the ratio of each.
The marketing authorization of 'Soliqua' in Europe covers the 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway, and is consonant with the favorable opinion issued by the Committee of Medicines for Human Use, of the AgencyEuropean Medicines (EMA), in November 2016.