EMA accepts filing of Forxiga for type 1 diabetes.- AstraZeneca.

AstraZeneca announced that the European Medicines Agency has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin), for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). 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 (24 week) and long-term (52 week) data from DEPICT-1, along with the short-term data from DEPICT-2, showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated 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. The safety profile of Forxiga in the DEPICT clinical programme to date is consistent with its established profile in type-2 diabetes (T2D), with the exception of a higher number of diabetic ketoacidosis (DKA) events in dapagliflozin-treated patients versus placebo in these T1D studies. DKA is a known complication for patients with diabetes that affects those with T1D more frequently than with T2D.

Comment: Forxiga is a first-in-class selective inhibitor of human sodium-glucose co-transporter 2 (SGLT-2 inhibitor) indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the added benefits of blood pressure reductions and weight loss in adult patients with type-2 diabetes (T2D).