EU approval for Suliqua (insulin glargine + lixisenatide combination) to treat type 2 diabetes.- Sanofi

Sanofi has announced that the European Commission has granted marketing authorization in Europe for Suliqua, the 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 authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

The decision to grant marketing authorization in Europe for Suliqua was based on data from two Phase III studies, LixiLan-O and LixiLan-L, which enrolled more than 1,900 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 (-0.8%, p<0.0001) and insulin glargine 100 Units/mL (-0.3%, p<0.0001) in LixiLan-O, and versus insulin glargine 100 Units/mL (-0.5%, p<0.0001) in LixiLan-L.

Suliqua will be delivered in two pre-filled SoloSTAR pens, providing different dosing options that may help answer individual market and patient insulin needs. The differentiation between the pen strengths is based on the dose range and ratios of each pen. The 10-40 SoloSTAR pre-filled pen will deliver 10 to 40 dose steps of insulin glargine 100 Units/mL in combination with 5 to 20 micrograms of lixisenatide. The 30-60 SoloSTAR pre-filled pen will deliver 30 to 60 dose steps of insulin glargine 100 Units/mL in combination with 10 to 20 micrograms of lixisenatide .

Comment: Sanofi received FDA approval on 21 November 2016 for Soliqua 100/33 (Sulquia in the EU) insulin glargine (Lantus) plus lixisenatide (Lyxumia).