Marketing authorisation granted for Steglujan.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Steglujan (ertugliflozin and sitagliptin), from Merck Sharp & Dohme, intended for the treatment of type 2 diabetes. Steglujan will be available as film-coated tablets (containing either 5 mg ertugliflozin and 100 mg sitagliptin, or 15 mg ertugliflozin and 100 mg sitagliptin).

Ertugliflozin works by blocking a protein in the kidney called the human sodium-glucose co-transporter-2 (SGLT2). This reduces glucose re-absorption in the kidney leading to glucose excretion in the urine. Sitagliptin 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 Steglujan is its ability to lower blood glucose. The most common side effects are vulvovaginal mycotic infection and other female genital mycotic infections. Serious diabetic ketoacidosis occurs rarely.

The full indication is: Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: and when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control; and in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.