Sanofi announced 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.
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.
“We welcome the addition of Suliqua in the EU to help address the needs of people living with type 2 diabetes who are currently not reaching their blood sugar targets,” said Javier Ampudia Blasco, Specialist of Endocrinology and Nutrition at the Clinic University Hospital Valencia and Associate Professor of Medicine at the Medicine Faculty of Valencia in Spain.
“It is important to achieve glycemic control without increasing the risk of hypoglycemic events or additional weight gain when oral agents or basal insulin are no longer sufficient. 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. Suliqua is easy to use with dose adjustments based only in the fasting glucose values.”
Marketing authorization in Europe for Suliqua is applicable to the 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway, and follows the November 2016 positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The product was approved by the U.S. Food and Drug Administration (FDA) in November 2016, as SoliquaTM 100/33, and has been available in the U.S. since January 4, 2017. Launches in individual EU countries are anticipated from Q2 2017 onward.