On January 27, the US Food and Drug Administration (FDA) approved the Type 2 diabetes medicine exenatide extended-release for injectable suspension (brand name Bydureon), manufactured by Amylin Pharmaceuticals. Bydureon is a member of the class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. (Exenatide [Byetta] and liraglutide [Victoza] are the other members of this drug class.)
GLP-1 agonists work by stimulating the insulin-producing beta cells of the pancreas to release insulin in response to high blood glucose levels. Because of their glucose-dependant mechanism of action, drugs of this class are associated with a low rate of hypoglycemia (low blood glucose).
Bydureon is an injected drug that is approved for use in conjunction with diet and exercise in people with Type 2 diabetes. Unlike all other diabetes medicines to date, Bydureon needs to be administered only once a week. The 2-milligram dose — which is packaged in a single-dose tray containing the medicine vial, vial connector, syringe, and needles (one as a spare) — can be injected at any time on the dosing day, with or without food. It should be administered under the skin in the abdomen, thigh, or upper arm.
The medicine, which is a modified version of the twice-daily injectable drug Byetta, was associated with a 1.6% reduction in A1C (an indicator of blood glucose control over the previous 2–3 months) over the course of a 24-week study, compared to a 0.9% A1C reduction in people taking Byetta. Those taking Bydureon also experienced an average weight loss of 5.1 pounds.
Bydureon was ultimately approved on its third attempt after a lengthy review process by the FDA to alleviate safety concerns. The label carries a warning stating that the medicine caused certain types of thyroid tumors in studies with rats, but that it is not known whether it causes such tumors in humans. Bydureon should not be used in people with a personal or family history of medullary thyroid cancer. The manufacturer will be assessing the impact of the medicine on both medullary thyroid cancer and cardiovascular events. Exenatide, the active ingredient in Bydureon, has also been associated with pancreatitis (inflammation of the pancreas), and people who are using this medicine should be evaluated for signs of this condition, including persistent, severe abdominal pain.
This medicine has not been studied in combination with insulin and should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body).
The most common side effects in people using Bydureon are nausea, diarrhea, headache, vomiting, constipation, itching at injection site, nodules (small bumps) at the injection site, and indigestion. Although nausea is common when starting on the medicine, it may decrease over time.
Bydureon is expected to be available in pharmacies this month.