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March 5, 2014

AstraZeneca obtains FDA approval for Bydureon Pen to treat type 2 diabetes

AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its Bydureon Pen (exenatide extended-release for injectable suspension) 2mg as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its Bydureon Pen (exenatide extended-release for injectable suspension) 2mg as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

Bydureon Pen is a pre-filled, single-use pen injector that eliminates the need for patients to transfer medication between a vial and syringe during self-injection.

It contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide.

The company said that trials of the Bydureon Pen had shown a reduction in blood glucose levels.

"We are committed to addressing the needs of adults with type 2 diabetes, including ongoing research to develop new treatments and methods of delivery."

Approval was based on the safety and efficacy data from the pivotal DURATION-5 clinical trial, when treatment with Bydureon resulted in improvements in glycaemic control.

The randomised open-label clinical trial was carried out in 252 adult patients with type 2 diabetes and inadequate glycaemic control with diet and exercise alone or with oral antidiabetic therapy, including metformin, a sulfonylurea, a thiazolidinedione or a combination of two of these oral type 2 diabetes medications comparing Bydureon to Byetta.

In the 24-week, randomised, open-label trial, once-weekly Bydureon showed an HbA1c reduction of 1.6% points vs 0.9% points for twice-daily Byetta (exenatide) injection at 24 weeks.

In addition, Bydureon showed a mean weight reduction of 2.3kg vs 1.4kg with Byetta.

AstraZeneca executive vice-president of global medicines development and chief medical officer Briggs Morrison said: "We are committed to addressing the needs of adults with type 2 diabetes, including ongoing research to develop new treatments and methods of delivery."

Bydureon Pen delivers exenatide via microsphere technology in a once-weekly dose requiring no titration and it can be administered at any time of the day, with or without meals.

The company intends to make the Bydureon Pen available for patients in the US later in 2014.

According to FDA, Bydureon should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis and it is not recommended as first-line therapy for patients who have inadequate glycaemic control on diet and exercise.

The once-weekly diabetes drug Bydureon is not a substitute for insulin and its concurrent use with insulin has not been studied, nor is it recommended.

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