CHMP recommended the use of Suliqua in combination with metformin for the treatment of adults with type 2 diabetes mellitus 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 CHMP positive opinion is 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.
Both studies met their primary endpoints, demonstrating statistically superior HbA1c reduction versus lixisenatide and insulin glargine 100 Units/mL in LixiLan-O,1 and versus insulin glargine 100 Units/mL in LixiLan-L.
Suliqua is the brand name in Europe for the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide.
The CHMP positive opinion will be forwarded to the European Commission, which has the authority to approve medicines for the European Union. A formal decision by the European Commission is expected in the coming months.
Once approved, Sanofi will make Suliqua(TM) available in the EU in two pre-filled SoloSTAR pens, providing different dosing options that will help answer individual market and patient needs. The differentiation between the pen strengths is based on the dose range of each pen.
The 10-40 SoloSTAR pre-filled pen will deliver 10 to 40 dose steps of insulin glargine 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 in combination with 10 to 20 micrograms of lixisenatide.
Zealand invented lixisenatide, a once-daily prandial GLP-1 receptor agonist, for the treatment of type 2 diabetes and granted global development and commercial rights to the product, including for use in combinations, to Sanofi.
Zealand president and CEO Britt Meelby Jensen said: "We are pleased that Sanofi received the positive opinion from the CHMP on Suliqua(TM) (iGlarLixi) in the EU. The opinion is supported by robust data from the LixiLan phase III program showing substantial benefits to patients with type 2 diabetes.
"Suliqua will be marketed by Sanofi and an approval is expected to provide significant revenue to Zealand in the years to come. We look forward to the European decision in the coming months as well as the upcoming FDA decision in the U.S."
This fixed-ratio combination is currently under review in a total of nine markets, including the United States, where a U.S. Food and Drug Administration decision is anticipated later this month.