AstraZeneca’s Forxiga accepted for EU review as type 1 diabetes therapy

AstraZeneca has announced that its selective SGLT-2 inhibitor therapy Forxiga has been accepted for European regulatory review as a treatment for type 1 diabetes.

The European Medicines Agency has accepted a marketing authorisation variation for Forxiga for use as an oral adjunct treatment to insulin in adults with type 1 diabetes, based on positive data from the phase III DEPICT-1 trial.

In this study, Forxiga was shown to demonstrate significant and clinically relevant reductions from baseline in blood glucose levels, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both five mg and ten mg doses.

Additionally, the safety profile of Forxiga in the DEPICT clinical programme to date has been shown to be broadly consistent with its established profile in type 2 diabetes.

If approved, Forxiga would become the first selective SGLT-2 inhibitor approved in Europe for the treatment of type 1 diabetes as an oral treatment adjunct to insulin, thereby addressing a significant unmet need in this patient population.

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