It 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 European Commission (EC) has approved Forxiga (dapagliflozin) as an adjunct to insulin in patients with a BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
“Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for people living with type-1 diabetes whose glucose levels are not adequately controlled with insulin alone. We look forward to bringing Forxiga to a patient population that has not had any approved oral medicines available before,” says Elisabeth Björk, Senior Vice President, Head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals, AstraZeneca.
Phase III DEPICT
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 in 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.
Under regulatory review in Japan and the US
Forxiga is currently under regulatory review in Japan and the US for use as an adjunct treatment to insulin in adults with T1D, with a decision expected in the first and second half of 2019, respectively.
Photo of Elisabeth Björk: AstraZeneca