EMA accepts regulatory submission for AstraZeneca's Forxiga in type 1 diabetes
The European Medicines Agency has accepted AstraZeneca's submission for Forxiga (dapagliflozin) as an oral adjunct treatment to insulin in adults with type 1 diabetes. This potential approval would mark a new indication for the drug.
AstraZeneca announced on March 5, 2018, that the European Medicines Agency (EMA) has accepted a Marketing Authorisation Variation for Forxiga (dapagliflozin). The submission seeks to expand the drug's use as an oral adjunctive therapy to insulin for adults diagnosed with type 1 diabetes (T1D).
The acceptance is based on Phase III data from the DEPICT clinical trial program. Results from DEPICT-1 and DEPICT-2 trials indicated that Forxiga, when used alongside adjustable insulin doses in patients with inadequately controlled T1D, demonstrated significant and clinically relevant reductions in HbA1c, weight, and total daily insulin dose at both 24 and 52 weeks compared to placebo.
Forxiga's safety profile in the DEPICT trials was consistent with its established profile in type 2 diabetes (T2D). However, a higher number of diabetic ketoacidosis (DKA) events were reported in dapagliflozin-treated patients compared to placebo. DKA is a known complication of diabetes that occurs more frequently in individuals with T1D.
If approved in Europe for T1D, Forxiga would become the first selective SGLT-2 inhibitor indicated for this condition. The drug is currently approved for type 2 diabetes, and its use in type 1 diabetes requires further regulatory review.