AstraZeneca Receives FDA Approval for Bydureon PenBy
AstraZeneca has received FDA approval for BydureonÂ® 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 is the first and only once-weekly medicine for adults with Type 2 diabetes. The Bydureon Pen is a prefilled, 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 Bydureon Pen contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide.
The Bydureon Pen delivers exenatide via microsphere technology in a once-weekly dose requiring no titration. It can be administered at any time of the day, with or without meals. AstraZeneca plans to make the Bydureon Pen available for patients in the US later this year. The Bydureon single-dose tray will remain on the market in the US for patients prescribed Bydureon. FDA approval for Bydureon was received in 2012. Bydureon is currently available in 42 countries worldwide, including European Union countries.