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# FDA Approves AstraZeneca NDA for Bydureon BCise
- URL: https://www.fdaweb.com/fda-approves-astrazeneca-nda-for-bydureon-bcise/
- Published: 2017-10-23T12:00:00.000Z
- Updated: 2026-09-14T22:57:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139940

FDA has approved an AstraZeneca NDA for Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation designed for an improved once-weekly, single-dose autoinjector device for adults with Type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines, in addition to diet and exercise, to improve glycemic control. “Unlike other glucagon-like peptide-1 (GLP-1) receptor agonists, Bydureon BCise has a unique, continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state,” the company says. “The new formulation in the innovative Bydureon BCise device is proven to reduce blood sugar levels, with the added benefit of weight loss, although not a weight loss medicine.”

Approval was based on data from two clinical trials that showed average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds were achieved when used as monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of two of these oral anti-diabetic medicines at 28 weeks, AstraZeneca says. The most common adverse reactions reported in clinical trials were nausea (8.2%) and adverse events associated with injection-site nodules (10.5%).