Paris, France - January 18th , 2017 - Sanofi announced today that the European Commission has granted marketing authorization in Europe for SuliquaTM, 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.
"Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe," said Elias Zerhouni, M.D., President, Global R&D, Sanofi. "The approval of Suliqua represents the successful culmination of a concerted effort by Sanofi scientists to bring two injectable treatments together in a single and precisely titratable dose. 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."
The decision to grant marketing authorization in Europe for Suliqua was 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. 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. Read more: https://globenewswire.com/news-release/2017/01/17/906426/0/en/Sanofi-SuliquaTM-Approved-in-the-European-Union-for-the-Treatment-of-Adults-with-Type-2-Diabetes.html