Glyxambi, a fixed-dose combination of Empagliflozin and Linagliptin, for the treatment of type 2 diabetes mellitus
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Glyxambi, intended for the treatment of type 2 diabetes mellitus.
Glyxambi is a fixed-dose combination of Empagliflozin and Linagliptin, two oral blood glucose lowering medicines. It is available as film-coated tablets ( containing either 10 mg Empagliflozin and 5 mg Linagliptin, or 25 mg Empagliflozin and 5 mg Linagliptin ).
Empagliflozin is a competitive, reversible, selective and orally active inhibitor of the human sodium-glucose co-transporter 2 ( SGLT2 ) which reduces renal glucose re-absorption leading to urinary glucose excretion.
Linagliptin is a dipeptidyl peptidase 4 ( DPP-4 ) inhibitor. DPP-4 inhibition reduces the cleavage and inactivation of the incretin hormone glucagon-like peptide 1 ( GLP-1 ), leading to an increase in incretin levels, which in turn stimulates glucose-dependent insulin secretion and inhibits the release of glucagon.
The benefit with Glyxambi is its ability to lower blood glucose.
The most common side effect was urinary tract infection ( 7.5% with Glyxambi 10 mg/5 mg and 8.5% with Glyxambi 25 mg/5 mg ).
The most serious adverse reactions were ketoacidosis ( less than 0.1% ), pancreatitis ( 0.2% ), hypersensitivity ( 0.6% ), and hypoglycaemia ( 2.4% ).
The full indication is: Glyxambi is indicated in adults aged 18 years and older with type 2 diabetes mellitus: a) to improve glycaemic control when Metformin and/or sulphonylurea and one of the monocomponents of Glyxambi do not provide adequate glycaemic control; b) when already being treated with the free combination of Empagliflozin and Linagliptin. ( Xagena )
Source: EMA, 2016