CHMP recommends approval of Steglatro for type 2 diabetes.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Steglatro (ertugliflozin), from Merck Sharp & Dohme, intended for the treatment of type 2 diabetes. Steglatro will be available as 5 mg and 15 mg film-coated tablets. 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. The benefit with Steglatro 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: Steglatro 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: as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications; and in addition to other medicinal products for the treatment of diabetes.