1 February 2019 - EMA’s CHMP has recommended for the first time an adjunct treatment to insulin in the form of a tablet for certain patients with type 1 diabetes mellitus.

Dapagliflozin is already authorised in the European Union as Forxiga and Edistride for the treatment of patients with type 2 diabetes. It belongs to a new generation of diabetes medicines called selective SGLT2 inhibitors that work in the kidneys to prevent reabsorption of glucose from the urine into the blood stream.

Following an assessment of data from new clinical trials, the CHMP is now recommending to extend the indication of dapagliflozin to certain patients with type 1 diabetes mellitus, when their insulin alone does not provide adequate control of their blood glucose levels despite optimal insulin therapy. Patients considered for this treatment should fulfil certain requirements and should not have a body mass index below 27 kg/m2.

Read EMA press release