FDA Approves Exenatide Extended-Release Injection for T2D

The Food and Drug Administration has approved Bydureon® BCise™ (exenatide extended-release injectable suspension; AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. 

This new formulation of Bydureon (exenatide extended-release) allows for once-weekly administration because of its continuous-release microsphere delivery system, designed to provide consistent therapeutic levels of exenatide. As the product is intended for self-administration, clinicians should train patients on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. 

In clinical trials, treatment with Bydureon BCise resulted in average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds when used as monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of 2 of these agents, at 28 weeks.

Prior treatment with an immediate- or extended-release exenatide product is not required when initiating Bydureon BCise. Patients should discontinue treatment with other exenatide products before starting treatment.

Bydureon BCise, a glucagon-like peptide-1 (GLP-1) receptor agonist, is supplied as 2 mg of exenatide per 0.85 mL suspension in a pre-filled disposable single-dose autoinjector. It is expected to be available in the first quarter of 2018.

Reference

US FDA approves new easy-to-use, once-weekly BYDUREON® BCise™ injectable medicine for patients with type-2 diabetes [news release]. Cambridge, UK: AstraZeneca. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2017/us-fda-approves-new-easy-to-use-once-weekly-bydureon-bcise-injectable-medicine-for-patients-with-type-2-diabetes-10232017.html. Published October 23, 2017. Accessed October 31, 2017. 

This article originally appeared on MPR