The European Commission (EC) has approved Forxiga (dapagliflozin) for use in Type 1 diabetes (T1D) as an adjunct to insulin in patients with a BMI greater than 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. This is the first approval of Forxiga for the treatment of patients with T1D. Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for adults with Type 1 diabetes and the first AstraZeneca medicine ever approved for Type 1 diabetes.
The approval is based on data from the Phase III 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 5mg daily, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-meaningful reductions from baseline in average blood glucose levels HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 and 52 weeks.
The safety profile of Forxiga in these T1D trials was consistent with its well-established profile for the treatment of Type 2 diabetes (T2D), with the exception of a higher number of diabetic ketoacidosis (DKA) events in Forxiga-treated patients. DKA is a known complication for adults with T1D that affects those with T1D more frequently than with T2D. Forxiga is already indicated as a monotherapy and as part of combination therapy in adults with T2D to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise.
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