AstraZeneca’s Forxiga (dapagliflozin), has been approved by the European Commission (EC) for type I diabetes.
The drug is the first oral medicine approved in Europe as an adjunct to insulin for adults with type I diabetes, and also the first AstraZeneca medicine ever approved for the disorder.
The approval is 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.
The approval is based on data from the Phase III DEPICT trial, in which the the short-term (24 week) and long-term (52 week) data showed that when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, 5mg daily of Forxiga significantly reduced average blood glucose levels HbA1c, which was the primary endpoint of the trial, along with weight and total daily insulin dose.
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.”
Forxiga is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) that is already indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise in adults with type II diabetes.