The European Medicines (EMA) Agency has accepted a marketing authorisation variation from United Kingdom-based AstraZeneca for selective SGLT-2 inhibitor Forxiga (dapagliflozin), intended for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D), it was reported yesterday.

The submission acceptance is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes) clinical programme for Forxiga in T1D.

The short-term and long-term data from DEPICT-1, along with the short-term data from DEPICT-2, indicated that the product, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, indicated significant and clinically-relevant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both 5 mg and 10 mg doses.

Forxiga has the potential to become the first selective SGLT-2 inhibitor approved in Europe for the treatment of T1D as an oral treatment adjunct to insulin.