AstraZeneca PLC said the European Commission approved Forxiga as a supplementary treatment to insulin for certain patients with type 1 diabetes.
Forxiga, also known as dapagliflozin, can now be used as an adjuvant to insulin to treat type 1 diabetes in patients with a body mass index of at least 27 kilograms per meter square, when insulin alone does not provide enough blood sugar control.
The approval was based on results from a late-stage study, dubbed Depict, which showed Forxiga improved glucose control without increasing the risk of hypoglycemia, or very low blood sugar levels, when given as an oral adjunct to insulin in patients with type 1 diabetes. The drug, which was given in 5-milligram daily doses and compared to placebo, also helped lower weight and total daily insulin requirement in patients after 24 weeks and 52 weeks of treatment.
On March 18, the U.K. drugmaker said results from a sub-analysis of a late-stage trial of Forxiga showed it cut the likelihood of a cardiovascular event by 16% in high-risk patients and reduced the chances of hospitalization for heart failure in all patients with the disease.
Taking Forxiga cut hospitalizations for heart failure by 36% in patients with a reduced ejection fraction — a measure of how much blood the heart pumps out with each contraction. For those without reduced ejection fraction, the drop in hospitalizations was 24%.
AstraZeneca is also seeking approvals in Japan and the U.S. for the same indication, with decisions expected in the first half and second half, respectively. Forxiga is marketed in the U.S. as Farxiga.