US FDA approves Bydureon® Pen (exenatide extended-release for injectable suspension) for once-weekly treatment of adults with type 2 diabetes

AstraZeneca today announced that the US Food and Drug Administration (FDA) has 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. BYDUREON should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis. BYDUREON is not recommended as first-line therapy for patients who have inadequate glycaemic control on diet and exercise. BYDUREON is not a substitute for insulin. The concurrent use of BYDUREON with insulin has not been studied and is not recommended.

BYDUREON is the first and only once-weekly medicine for adults with type 2 diabetes. The BYDUREON 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 BYDUREON Pen contains the same formulation and dose as the original BYDUREON single-dose tray, providing the same continuous release of exenatide.

BYDUREON has been 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 vs 0.9 percentage points for twice-daily BYETTA® (exenatide) injection at 24 weeks (baseline HbA1c 8.5 percent and 8.4 percent, respectively). Additionally, BYDUREON demonstrated a mean weight reduction of 2.3 kg vs 1.4 kg with BYETTA (baseline 97 kg and 94 kg, respectively). BYDUREON is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.

“We’re pleased to receive approval for the BYDUREON Pen, which can provide a powerful reduction in blood glucose levels along with the potential benefit of weight loss, through a once-weekly dose in a pre-filled device,” said Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca. “We are committed to addressing the needs of adults with type 2 diabetes, including ongoing research to develop new treatments and methods of delivery.”

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.

The FDA approval for BYDUREON was received in 2012. BYDUREON is currently available in 42 countries worldwide, including European Union countries.