EU Approves Suliqua for Type 2 Diabetes Treatment

The European Commission has given Sanofi the green light to begin marketing Suliqua to treat adults with type 2 diabetes.

The once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide treatment is authorized to use in combination with metformin primarily to improve glycemic control. Experts are advised to administer this injectable treatment when metformin alone or combined with another oral glucose-lowering medicinal could not do the trick.

The final decision was based on data from two global phase 3 studies — LixiLan-O and LixiLan-L – which included more than 1,900 adults with type 2 diabetes to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations.

Study results indicated that Suliqua exhibited “statistically superior” blood sugar reduction compared with lixisenatide and insulin glargine 100 units/mL in LixiLan-O and insulin glargine 100 units/mL in LixiLan-L.

The medication will be delivered in two pre-filled SoloSTAR pens to provide different dosing options that could target individual patient needs. The 10-40 SoloSTAR pen will aim to deliver 10 to 40 dose steps of insulin glargine 100 units/mL combined with five to 20 micrograms of lixisenatide. The 30-60 SoloSTAR pen will administer 30 to 60 dose steps of insulin glargine 100 units/mL combined with 10 to 20 micrograms of lixisenatide.

According to experts, it’s important to attain glycemic control without increasing the risk of hypoglycemic events or weight gain whenever basal insulin is insufficient. “The simple administration of this combination product of insulin and a glucagon-like peptide-1 receptor agonist in a single daily injection may help to reduce the daily complexity of diabetes management and improve efficacy for people with type 2 diabetes compared with its components,” authors concluded.