AstraZeneca’s Forxiga (dapagliflozin) has been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) as an oral adjunct treatment to insulin in adults with type I diabetes.
Forxiga is a selective sodium glucose cotransporter-2 (SGLT2) inhibitor, the first oral medicine to receive a positive recommendation from the EMA for use in type I diabetes as an adjunct to insulin, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
The positive opinion is based on Phase III data from the DEPICT clinical programme, which consisted of two trials, DEPICT-1 and -2, and demonstrated that Forxiga, when given as an oral adjunct to adjustable insulin in adults with inadequately-controlled type I diabetes, showed significant reductions from baseline in HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 and 52 weeks versus placebo, at both 5mg and 10mg doses.
Elisabeth Björk, vice president, head of Cardiovascular, Renal and Metabolism, BioPharmaceuticals, said: “People with type I diabetes have not seen oral treatment innovation in decades and we believe today’s announcement signals an important advancement for them, as well as a broader understanding of the well-established clinical profile of Forxiga for people living with metabolic diseases.”
The drug is also currently under regulatory review in the US and Japan for use as adjunct treatment to insulin in adults with the disorder.