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FDA approves the extended-release Bydureon Pen for the treatment of type 2 diabetes.
FDA approved the 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, AstraZeneca announced in a press release. Bydureon is the first once-weekly medicine for adults with type 2 diabetes. The Bydureon Pen is a pre-filled, single-use pen injector that delivers exenatide via microsphere technology in a once-weekly dose requiring no titration. The Bydureon Pen contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide.
“We are committed to addressing the needs of adults with type 2 diabetes, including ongoing research to develop new treatments and methods of delivery,” said Briggs Morrison, executive vice-president, Global Medicines Development and Chief Medical Officer, AstraZeneca, in the press release.
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. Bydureon should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis and is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. According to the company, Bydureon is not a substitute for insulin; the concurrent use of Bydureon with insulin has not been studied and is not recommended.