Company announcement - No. 44/2016CHMP issues positive opinion recommending Suliqua(TM) (iGlarLixi) for approval in the EU
Positive opinion based on data from two Phase III studies, LixiLan-O and LixiLan-L
Final decision from the European Commission expected in the coming months
Copenhagen, Denmark, Nov. 11, 2016 (GLOBE NEWSWIRE) -- Zealand Pharma (Zealand) today announced that Sanofi has received a positive opinion from the Committee for Medicinal Product for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of Suliqua(TM), 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. CHMP recommended the use of Suliqua(TM) 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. The CHMP positive opinion is based on data from two Phase III 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,1 and versus insulin glargine 100 Units/mL in LixiLan-L. Suliqua(TM) 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 CHMP positive opinion will be forwarded to the European Commission, which has the authority to approve medicines for the European Union. A formal decision by the European Commission is expected in the coming months.