Edistride(dapagliflozin)

Edistride (dapagliflozin) is a drug for which a Marketing Authorisation application was submitted on 3 July 2015, following eligibility to the centralised procedure being agreed by EMA/CHMP on 26 February 2015. A CHMP positive opinion for Marketing Authorisation was issued on 24 September 2015. The Community Marketing Authorisation date for Forxiga, which contains the same active substance, was 12 November 2012.

Safety findings indicate that the proportion of subjects with malignant or unspecified tumours was 1.50% for both dapagliflozin and placebo/comparator. In subjects aged 65 years and older, adverse reactions related to renal impairment or failure were observed in 7.7% of dapagliflozin-treated subjects compared to 3.8% in placebo-treated subjects. Adverse reactions of volume depletion in subjects aged 65 years and older were 1.7% for dapagliflozin and 0.8% for placebo. Urinary tract infection incidence in the placebo group was 3.5%. Minor hypoglycaemia incidence was 6.0% for dapagliflozin 10 mg + glimepiride, compared to 2.1% for placebo + glimepiride, and 7.9% for dapagliflozin 10 mg + glimepiride in another instance.