FDA Approves Bydureon Pen (Exenatide) for Once-Weekly Treatment of Adults With Type 2 Diabetes
Device will be available later this year
The FDA has approved the Bydureon pen (exenatide extended-release for injectable suspension, AstraZeneca) 2 mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
The device is a prefilled, single-use pen injector, eliminating the need for patients to transfer the medication between a vial and a 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 pen can be administered at any time of the day, with or without meals.
In a 24-week, randomized, open-label trial, once-weekly Bydureon demonstrated a hemoglobin A1c (HbA1c) reduction of 1.6 percentage points versus 0.9 percentage points for twice-daily exenatide injection (Byetta, Bristol-Myers Squibb/AstraZeneca) at 24 weeks (baseline HbA1c: 8.5% and 8.4%, respectively). In addition, once-weekly Bydureon demonstrated a mean weight reduction of 2.3 kg versus 1.4 kg with exenatide (baseline: 97 kg and 94 kg, respectively).
The Bydureon pen should not be used for the treatment of patients with type 1diabetes or diabetic ketoacidosis. Moreover, the device is not recommended as first-line therapy for patients with inadequate glycemic control on diet and exercise. The concurrent use of the Bydureon pen with insulin has not been studied and is not recommended.
The pen will be available for patients in the U.S. later this year. The single-dose tray will remain on the market in the U.S. for patients prescribed Bydureon.
Source: AstraZeneca; March 3, 2014.