New Indication for Bydureon
April 2, 2018 – The U.S. FDA has approved a new indication for Bydureon® (exenatide extended release), manufactured by AstraZeneca. It is now approved for use with insulin glargine to manage type 2 diabetes in adults who have not achieved adequate control of their blood sugar on other medications.
Approval for the new indication is based on a clinical study in which patients who received Bydureon and insulin glargine had improved A1c levels, an indicator used to measure the success of diabetes management, compared to patients who received insulin glargine and a placebo.
Bydureon works similarly to a hormone known as a glucagon-like peptide-1 (GLP-1), which the body creates based on food intake. The GLP-1 hormone plays several roles that affect blood sugar levels in the body. It can increase insulin production, decrease glucose production, slow the rate of glucose absorption into the bloodstream, and affect when the stomach feels full.
When used in conjunction with insulin, Bydureon may raise the risk of hypoglycemia. It carries a black box warning that cautions it should not be used by patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), as its use may be tied to the development of thyroid tumors.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.