Bydureon BCise Approved for Type 2 Diabetes
October 20, 2017 – The U.S. FDA has approved Bydureon BCise™ (exenatide extended release), manufactured by AstraZeneca. Bydureon BCise is indicated as an adjunct to diet and exercise to treat adult patients with type 2 diabetes who need additional assistance lowering blood sugar levels when diet, exercise, and oral diabetes treatments have not been sufficient. The drug may also help patients lower their weight.
Bydureon BCise is a new formulation of AstraZeneca’s Bydureon, and will be available in a disposable, prefilled auto-injector containing 2mg of the drug, with a recommended dosing schedule of once per week. The BCise formulation uses continuous-release microspheres to achieve consistent levels of medication in the body, allowing for less frequent administration. Before using Bydureon BCise, patients should receive instruction from their healthcare provider on proper administration techniques.
A glucagon-like peptide-1 (GLP-1) receptor agonist, Bydureon BCise should not be used with insulin, and should not be used as the first treatment option for diabetes or in conjunction with other exenatide products. The drug carries a black box warning against its use by individuals and relatives of individuals who have medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). GLP-1 agonists like Bydureon BCise have been associated with thyroid tumors such as those involved in MTC and MEN2. The drug is not recommended for use in patients with a history of pancreatitis.
AstraZeneca plans to make Bydureon BCise available in the first quarter of 2018.
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.