The European Medicines Agency has accepted AstraZeneca’s Marketing Authorisation Variation for Forziga in adults with type-1 diabetes (T1D).
The submission acceptance is based on Phase III data from the DEPICT 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.
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.
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, helping to address a significant unmet need in this patient population.