AstraZeneca Gets US Approval For Bydureon Pen

LONDON (Alliance News) - AstraZeneca PLC Monday said the US Food and Drug Administration has approved its Bydureon Pen injectable suspension treatment for type 2 diabetes as an adjunct to diet and exercise to improve glycaemic control in adults.

In a statement, the drugs giant said that Bydureon should not be used to treat type 1 diabetes or diabetic ketoacidosis and is also not recommended as a first-line therapy for patients who have inadequate glycaemic control on diet and exercise alone. It is also not a substitute for insulin.

"Bydureon is the first and only once-weekly medicine for adults with type 2 diabetes. The Bydreon Pen is a pre-filled, single-use pen injector, eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process," the company said in a statement.

The company says the treatment can quickly reduce blood glucose levels at the same time as potentially helping weight loss.

It said it plans to launch the pen treatment in the US later this year. Bydureon is currently sold as a single-dose tray.

By Steve McGrath; stevemcgrath@alliancenews.com; @SteveMcGrath1

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