Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of SuliquaTM, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide. 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.
“We welcome the CHMP positive opinion for Suliqua and look forward to the final decision of the European Commission (EC), as well as the upcoming U.S. Food and Drug Administration decision,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “Today’s opinion brings us one step closer to delivering in Europe this important and innovative treatment option, which combines two widely used and complementary medicines into a single daily injection that we feel will benefit people with type 2 diabetes who are struggling to keep their blood sugar levels under control.”
The CHMP positive opinion is based on data from two Phase 3 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, 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 European Commission is expected to make a final decision on marketing authorization for Suliqua in the coming months. The 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.
Once approved, Suliqua will be 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.