The European Commission has granted marketing authorisation in Europe for SuliquaTM, Sanofi’s once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
Suliqua is authorised for use in combination with metformin to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.
Suliqua will be delivered in two pre-filled SoloSTAR® pens, providing different dosing options that may help to answer individual market and patient insulin needs.
The decision to grant marketing authorisation in Europe for Suliqua was based on data from two Phase 3 studies, LixiLan-O and LixiLan-L. The trial enrolled more than 1900 adults with type 2 diabetes worldwide to evaluate the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled after OADs and after basal insulin therapy, respectively. Suliqua demonstrated statistically superior blood sugar (HbA1c) reduction versus lixisenatide and insulin glargine 100 Units/mL in LixiLan-O, and versus insulin glargine 100 Units/mL in LixiLan-L.
Elias Zerhouni, President, Global R&D, Sanofi, said: “Sanofi has a long history of elevating care for people with diabetes, and we believe Suliqua will make it easier for patients with inadequately controlled diabetes to reach their treatment goals.”
Marketing authorisation in Europe for Suliqua is applicable to the 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. It follows the November 2016 positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency.