The FDA has approved an auto-injector and new formulation of a once-weekly treatment for type 2 diabetes from AstraZeneca. Bydureon BCise offers a single-dose auto-injector for adults with type 2 diabetes. Bydureon BCise features a unique continuous-release microsphere technology delivery system that provides consistent levels of the product’s active ingredient, exenatide. The new formulation has shown the ability to reduce blood sugar levels alongside weight loss, despite not being a weight loss medication. The medication is administered in 3 simple steps: mix, unlock and inject, and is prefilled with a pre-attached hidden needle.
Bydureon BCise is indicated as an adjunct to diet and exercise, and is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Across 2 clinical trials, 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 2 oral anti-diabetic medications at 28 weeks. Most common adverse effects which affected more than 5% of participants in clinical trials include injection-site nodule (10.5%) and nausea (8.2%).
Bydueron BCise will be available for patients in the U.S. in the first quarter of 2018. (See Item #3.) — News Release Oct, 18, 2017