FDA Approves Once-Weekly Diabetes Option
The FDA has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation for Bydureon in a once-weekly, single-dose autoinjector device for the treatment of adults with type 2 diabetes whose blood sugar remains uncontrolled despite one or more oral medications and diet and exercise.
The drug uses a continuous-release microsphere delivery system to provide consistent therapeutic levels of exenatide to patients.
The approval was based on the results of 2 clinical trials, in which average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds were achieved with Bydureon BCise monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of 2 of these oral medications at 28 weeks.
The most common adverse reactions were nausea and events related to injection-site nodules.
US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type-2 diabetes [press release]. AstraZeneca. October 23, 2017. https://www.astrazeneca.com/media-centre/press-releases/2017/us-fda-approves-new-easy-to-use-once-weekly-bydureon-bcise-injectable-medicine-for-patients-with-type-2-diabetes-231017.html.