AstraZeneca Plc. (AZN.L, AZN) Monday said the US Food and Drug Administration has approved Bydureon Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.
Bydureon should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis. It is not recommended as first-line therapy for patients who have inadequate glycaemic control on diet and exercise.
Also, Bydureon is not a substitute for insulin. The concurrent use of Bydureon with insulin has not been studied and is not recommended, the drugmaker added.
The drug has shown to provide powerful HbA1c (blood glucose level) reduction. In a 24-week, randomised, open-label trial, once-weekly Bydureon demonstrated an HbA1c reduction of 1.6 percentage points versus 0.9 percentage points for twice-daily Byetta (exenatide) injection at 24 weeks.
Additionally, Bydureon demonstrated a mean weight reduction of 2.3 kg compared to 1.4 kg with Byetta.
Bydureon is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.
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