New SGLT2 inhibitor receives positive opinion of EMA for the treatment of T2DM

EMA has granted a marketing authorization for the SGLT2 inhibitor ertugliflozin, as an adjunct to diet and exercise to improve glycemic control.

On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product ertugliflozin, intended for the treatment of type 2 diabetes.

Ertugliflozin will be available as 5 mg and 15 mg film-coated tablets. It is a blood glucose lowering agent. 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 most common side effects are vulvovaginal mycotic infection and other female genital mycotic infections. Serious diabetic ketoacidosis occurs rarely.

The full indication is:

“Ertugliflozin 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;
• in addition to other medicinal products for the treatment of diabetes.

Source: press release EMA January 25, 2018