The European Medicines Agency has accepted AstraZeneca’s filing for Forxiga as a treatment for diabetes type I.
The submission contains data from the Phase III DEPICT clinical programme, which showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled diabetes type I, induced significant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo.
On the safety side, the drug’s profile was consistent with that established for its use in patients with type II diabetes, except for a higher number of diabetic ketoacidosis (DKA) events, known to occur more frequently in patients with type I disease, AZ said.
Forxiga is a first-in-class SGLT-2 inhibitor which has been on the market in Europe since 2012 for patients with type II diabetes, as both monotherapy and as part of combination therapy to improve blood sugar levels, with the added benefits of blood pressure reductions and weight loss.
With this submission, the drug could potentially become the first selective SGLT-2 inhibitor approved in the region for the treatment of type I diabetes as an oral treatment adjunct to insulin, “helping to address a significant unmet need in this patient population,” the firm noted.