AstraZeneca announced Monday that the European Commission approved Forxiga (dapagliflozin) for use in type 1 diabetes as an adjunct to insulin in patients with a BMI of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. The company noted that this is the first clearance of the SGLT2 inhibitor in patients with type 1 diabetes.
Elisabeth Björk, head of late cardiovascular, renal and metabolism, R&D biopharmaceuticals, at AstraZeneca, said "Forxiga is the first oral medicine approved in Europe" in this indication. The drug is currently under regulatory review in Japan  and the US for use as an adjunct treatment to insulin in adults with type 1 diabetes, with decisions expected in the first and second half of 2019, respectively.
AstraZeneca noted that approval in Europe was based on findings from the Phase III DEPICT, with short-term and long-term data from DEPICT-1 , along with short-term results from DEPICT-2, showing that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled type 1 diabetes, demonstrated significant reductions from baseline in average blood glucose levels HbA1c, weight and total daily insulin dose at 24 and 52 weeks.
Forxiga, which is sold as Farxiga in some markets, is currently indicated as a monotherapy and as part of combination therapy in adults with type 2 diabetes to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise. Sales of the product reached nearly $1.4 billion in 2018.