Bydureon不应用于1型糖尿病或糖尿病痛症酸中毒（diabetic ketoacidosis）的治疗。同时，不建议将Bydureon用于饮食和运动不能充分控制血糖的2型糖尿病患者的一线治疗。Bydureon不能代替胰岛素。Bydureon与胰岛素联合用药尚未研究，因此不推荐2者联用。
Bydureon（exenatide，艾塞那肽长效缓释注射悬液）是用于2型糖尿病治疗的首个也是唯一一种每周一次的药物，于2012年获FDA批准，该药已在48个国家上市，包括欧盟。
Bydureon Pen则是一种预填充的、一次性使用的笔式注射器，省去了患者在药瓶和注射器之间转移药物的麻烦。
在临床研究中，Bydureon已被证明能够提供强大的糖化血红蛋白（HbA1c）水平降低。一项为期24周、随机、开放标签试验中，Bydureon（每周注射1次）治疗组HbA1c水平平均降低了1.6个百分点，而Byetta（exenatide，艾塞那肽，每天注射2次）治疗组HbA1c水平平均降低了0.9个百分点（HbA1c基线水平分别为8.5%和8.4%）。此外，Bydureon治疗组患者体重平均降低2.3kg，Byetta治疗组则为1.4kg（基线体重分别为97kg和94kg）。Bydureon不适用于肥胖的管理，体重变化仅为该研究的次要终点。
Bydureon Pen通过微球技术递送每周1次剂量的艾塞那肽，患者使用时无需滴定，并且可在一天中的任何时间给药。阿斯利康计划于今年晚些时候在美国推出Bydureon Pen。（生物谷Bioon.com）
英文原文：AstraZeneca gets FDA approval for Bydureon pen
Monday, 3 March 2014
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.