FDA approves exenatide ER pen for diabetes

Bringing a new tool to the arsenal of medications to treat type 2 diabetes, FDA recently approved the only once-weekly injectable pen for adults with type 2 diabetes-exenatide extended-release for injectable suspension (AstraZeneca, Bydureon Pen).

The 2-mg pre-filled, single-use pen for injection eliminates the need for the patient to transfer the medication between a vial and syringe during the self-injection process, according to AstraZeneca. The 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 said in a statement.

The manufacturer plans to make the pen available for patients in the United States later this year, and the Bydureon single-dose tray will remain on the market in the United States for patients prescribed Bydureon.

In a 24-week, randomized, open-label trial, once-weekly Bydureon demonstrated an HbA_1c reduction of 1.6 percentage points vs. 0.9 percentage points for twice-daily exenatide (Byetta) injection at 24 weeks, according to an AstraZeneca statement. Additionally, Bydureon demonstrated a mean weight reduction of 2.3 kg vs. 1.4 kg with exenatide (baseline 97 kg and 94 kg, respectively).

The Bydureon Pen should be used in addition to diet and exercise to improve glycemic control in adults with type 2 diabetes, and should not be used to treat patients with type 1 diabetes or diabetic ketoacidosis, according to AstraZeneca.

In addition, the medication is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise nor is it a substitute for insulin. “The concurrent use of Bydureon with insulin has not been studied and is not recommended,” AstraZeneca said in the statement.