Posted by Michael Wonder on 05 Mar 2018
The EMA accepts regulatory submission for Forxiga in adults with type-1 diabetes
5 March 2018 - First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes.
AstraZeneca today announced that the EMA has accepted the marketing authorisation variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, 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.
