The European Commission has cleared Sanofi’s Suliqua in combination with metformin, type 2 diabetes treatment, for European adult patients.
Saliqua is the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide. Suliqua/metformin combination should improve glycemic control with the patients who are currently not reaching their blood sugar targets with metformin alone or in different combinations.
It was approved for the US market in November 2016, as SoliquaTM 100/33, and has been available in the U.S. since January 4, 2017.
Elias Zerhouni, M.D., President, Global R&D, Sanofi, said that the approval of Suliqua represents the success for Sanofi scientists who combined two injectable treatments 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,” Zerhouni commented.
The approval for Saliqua came after it was tested little less than 2000 patients in two phase 3 studies. Suliqua showed 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 study, and versus insulin glargine 100 Units/mL (-0.5%, p<0.0001) in another study called LixiLan-L.
Suliqua will be delivered in two pre-filled SoloSTAR pens.
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, said: “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.”
In Europe, Suliqua will be available in the 28 EU member states, plus Iceland, Liechtenstein and Norway.