Sanofi on 18th Jan 2017 declared that the EU Commission has given a go ahead to market Suliqua in Europe, the daily once titratable fixed dose combo of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the therapy of adults with type 2 diabetes. Suliqua is approved for use in combination with metformin to enhance glycemic control when metformin by itself or metformin combined with a different oral glucose decreasing medicinal product or with basal insulin have not been effective.
Commenting on the approval Sanofi M.D., President, Global R&D,Elias Zerhouni said,
“Suliqua is a novel new combination therapy that addresses important unmet needs for individuals living with type 2 diabetes in Europe”. The acceptance of Suliqua shows the successful end result of a serious effort by Sanofi scientists to deliver two injectable treatments collectively in a single and precisely titratable dose. Sanofi has a long record of increasing care for individuals with diabetes, and we think Suliqua will make it simpler for sufferers with insufficiently controlled diabetes to reach their therapy goals.
The choice to grant approval in Europe for Suliqua was dependent on data from two Phase 3 studies, LixiLan-O and LixiLan-L, which registered over 1,900 adults with type 2 diabetes globally to assess the efficacy and safety of the fixed ratio combination when used in patient populations inadequately controlled following OADs and following basal insulin therapy, respectively. Suliqua exhibited statistically outstanding blood sugar (HbA1c) reduction vs lixisenatide (-0.8%, p<0.0001) and insulin glargine 100 Units/mL (-0.3%, p<0.0001) in LixiLan-O, and vs insulin glargine 100 Units/mL (-0.5%, p<0.0001) in LixiLan-L.
Suliqua will be provided in two pre-filled SoloSTAR pens, giving different dosing choices that may assist answer individual market and patient insulin requirements. The difference between the pen strengths is dependent on the dose range and ratios of each pen. The 10-40 SoloSTAR pre-filled pen will offer 10 to 40 dose steps of insulin glargine 100 Units/mL in combo with 5 to 20 micrograms of lixisenatide. The 30-60 SoloSTAR pre-filled pen will offer 30 to 60 dose steps of insulin glargine 100 Units/mL in combo with 10 to 20 micrograms of lixisenatide.
Javier Ampudia Blasco, Specialist of Endocrinology and Nutrition said,
“We welcome the inclusion of Suliqua in the EU to assist address the requirements of individuals living with type 2 diabetes who are presently not attaining their blood sugar targets.” “It is essential to obtain glycemic control without increasing the possibility of hypoglycemic events or extra weight gain when oral agents or basal insulin are no longer adequate. The simple administration of this combo product of insulin and a glucagon-like peptide-1 receptor agonist in a single daily injection may assist to decrease the daily complexness of diabetes management and enhance efficacy for individuals with type 2 diabetes in comparison with its components. Suliqua is simple to use with dose adjustments based only in the fasting glucose values.”
Marketing approval in Europe for Suliqua is applicable to the all 28 member states of the European Union, along with Iceland, Liechtenstein and Norway, and comes after the November 2016 positive opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The product was accepted by the U.S. Food and Drug Administration (FDA) in November 2016, as SoliquaTM 100/33, and has been accessible in the U.S. since January 4, 2017. Availability in EU countries are expected from Q2 2017 onward.