CHMP recommends Suliqua, combination of insulin glargine and lixisenatide, intended for the treatment of type 2 diabetes.- Sanofi.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Suliqua, intended for treatment of type 2 diabetes. The applicant for this medicinal product is Sanofi-aventis Groupe. Suliqua is a fixed-ratio combination of insulin glargine, a basal insulin analogue, and lixisenatide, a glucagon-like peptide 1 (GLP-1) receptor agonist. Insulin glargine binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin. Lixisenatide acts via enhancing glucose-dependent insulin secretion and reducing glucagon release. Suliqua will be available as a solution for injection (insulin 100 units/ml with lixisenatide 33 or 50 micrograms/ml). The benefits with Suliqua are its clinically relevant effect on glycaemic control in patients with type 2 diabetes when used in combination with metformin. Suliqua has a neutral effect on body weight. The most common side effects are hypoglycaemia, dizziness and gastrointestinal adverse reactions such as nausea and diarrhoea. The full indication is: "Suliqua is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin".

Comment; The combination was filed at the FDA in December 2015 as LixiLan ( now iGlarLixi) and an advisory committee has recommended approval for the treatment of adults with type 2 diabetes.