AstraZeneca's Forxiga Label Expansion Filing Accepted In EU

AstraZeneca AZN announced that the European Medicines Agency has accepted the Marketing Authorization Variation for the label expansion of Forxiga (dapagliflozin).

Forxiga, a selective SGLT-2 inhibitor, is presently marketed both as a monotherapy as well as a combination therapy to improve glycaemic controlin adult patients with type-2 diabetes (T2D).

With the MAV, AstraZeneca is seeking to get Forxiga approved as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). The submission to EMA was based on phase III data from the DEPICT study which showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, led to significant and clinically-relevant reductions from baseline in blood sugar levels (HbA1c), weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both 5 mg and 10 mg doses.

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