AstraZeneca's oral diabetes treatment gets European regulatory approval
Source - SMW
AstraZeneca said European regulators had approved its supplementary oral treatment for overweight type-one diabetic patients, whose glucose levels were not adequately controlled with insulin alone.
'The European Commission (EC) has approved Forxiga (dapagliflozin) for use in type-1 diabetes (T1D) 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 company said.
This marked the first approval of Forxiga for the treatment of patients with T1D.
The approval was based on data from the Phase III DEPICT clinical programme for Forxiga in T1D.
Results from the trial had demonstrated significant and clinically-meaningful reductions from baseline in average blood glucose levels HbA1c, weight and total daily insulin dose at 24 and 52 weeks.