The European Commission has approved Forxiga (dapagliflozin) for use in type-1 diabetes as an adjunct to insulin in cases when insulin alone does not provide adequate control.
This is the first approval of Forxiga for the treatment of patients with type-1, formerly known as Juvenile Diabetes.
Elisabeth Björk, senior vice president, head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals, said: “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.”
The approval is based on data from the Phase III trial.
The safety profile of Forxiga in these T1D trials was consistent with its well-established profile in type-2 diabetes with the exception of a higher number of diabetic ketoacidosis in Forxiga-treated patients.
Forxiga is currently under regulatory review in Japan and the US for use as an adjunct treatment to insulin in adults with type-1, with a decision expected in the first and second half of 2019, respectively.
Approximately five percent of people living with diabetes have type-Different factors, including genetics and some viruses, may contribute to type-1 diabetes.
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