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FDA Approves Weekly Exenatide Pen for Type 2 Diabetes Patients

Mar 6, 2014

The pre-filled, single-use pen injector eliminates the need for patients to transfer the medication between a vial and a syringe…. 

Bydureon is the first and only once-weekly medicine for adults with type 2 diabetes. It contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide. It has been shown to provide powerful HbA1c (blood glucose level) reduction. In a 24-week, randomized, 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% and 8.4%, respectively). Additionally, Bydureon demonstrated a mean weight reduction of 5.1 pounds (2.3 kg) vs 3.1 pounds (1.4 kg) with Byetta (baseline 213.8 pounds [97 kg] and 207.2 pounds [94 kg], respectively). It will also come with the same boxed warning on the risk of thyroid C-cell tumors, such as medullary carcinoma. AstraZeneca also noted post-marketing findings of a potential increased risk of pancreatitis with the drug, including fatal and nonfatal hemorrhagic and necrotizing pancreatitis.

Bydureon was submitted to the FDA in 2009 but the agency had questions about cardiovascular side effects, pancreatitis, and thyroid cancers. When the agency approved it 2 years ago, it came with a risk evaluation and mitigation strategy (REMS). It has been on the market in Europe since mid-2011.

FDA News 3-3-2015