The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of Bydureon (exenatide extended-release for injectable suspension; Amylin) outweigh the potential risks including medullary thyroid carcinoma (MTC) and acute pancreatitis. Bydureon is a once-weekly GLP-1 receptor agonist recently approved for the treatment of type 2 diabetes. Because of these potential risks, Bydureon is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
Amylin is establishing a medullary thyroid carcinoma (MTC) case series registry to systematically monitor the annual incidence of MTC in the U.S. This study will be designed to identify if there is any increased risk of MTC related to the introduction of Bydureon into the marketplace and will also characterize patient medical histories related to diabetes and use of Bydureon.
For more information about the MTC registry, call (877) 700-7365 or visit www.Bydureon.com/REMS.