Article
Type 2 Diabetes Treatment Gets FDA OK
The single-dose autoinjector device has a continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state.
Officials with the FDA have approved a new formulation of exenatide extended-release injectable suspension (Bydureon BCise, AstraZeneca) 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 glycaemic control.
The single-dose autoinjector device has a continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state.
Across 2 clinical trials, average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds (1.4 kilograms) 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.
The most common adverse reactions reported in ≥5% of patients in clinical trials were nausea (8.2%) and adverse events associated with injection-site nodules (10.5%).
Reference
US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type-2 diabetes [news release]. 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. Accessed October 23, 2017.
