AstraZeneca announces FDA approval of Bydureon for use in T2D patients
AstraZeneca (AZN) announced the FDA has approved BYDUREON for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes with inadequate glycemic control.
BYDUREON is approved for adults with T2D whose blood sugar remains uncontrolled on one or more antidiabetic medicines in addition to diet and exercise, to improve glycemic control.
The expanded use is based on results from the 28-week DURATION-7 study, which examined the effect of BYDUREON or placebo as add-on therapy to insulin glargine, with or without metformin, in adults with T2D.
Mean HbA1c was reduced by 0.9% in the BYDUREON group compared to 0.2% in the placebo group in patients with a mean baseline HbA1c of 8.5%.
Furthermore, 32.5% of patients in the BYDUREON group reached an HbA1c of less than 7.0% compared to 7.0% of patients in the placebo group.
There were no new safety findings in the DURATION-7 study.
Overall hypoglycemia was similar between the groups, with no reported major hypoglycemia.
In both arms, the same percentage of patients reported minor hypoglycemia. Like other GLP-1 receptor agonists, the risk of hypoglycemia is increased when BYDUREON is co-administered with insulin. Prescribers should consider lowering the dose of insulin when co-administering BYDUREON.
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