The Food and Drug Administration (FDA) has approved AstraZeneca’s Bydureon Pen, a pre-filled, single-use, pen-style delivery system for the injectable type 2 diabetes drug Bydureon.
Bydureon, also known as exenatide, was approved by the FDA in 2012. It is the first and only once-weekly medicine to treat type 2 diabetes in adults. The Bydureon Pen eliminates the need for the patient to transfer the medication between a vial and syringe during the self-injection process. The pen contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide.
Bydureon is in a class of medications called incretin mimetics, which improve blood sugar control by mimicking the action of a hormone called glucagon-like peptide (GLP-1). Others in this class include Byetta (which also contains the active ingredient exenatide) and Victoza (which contains liraglutide). Byetta is injected twice daily and Victoza is injected once a day.
All three drugs, as well as a DDP-4-type of incretin mimetic called Januvia (which contains sitagliptin), can increase the risk of acute pancreatitis, a painful inflammation of the pancreas. New research indicates acute pancreatitis increases the risk for pancreatic cancer.
Pancreatic cancer is one of the most deadly forms of cancer. Only four percent of people with the disease live five years or more after diagnosis.
AstraZeneca plans to mke the Bydureon Pen available for patients in the United States later this year.