FDA Approves Once-Weekly Bydureon BCise for Type-2 Diabetes

The US Food and Drug Administration (FDA) has approved Bydureon BCise (exenatide extended-release) injectable suspension for adults with type-2 diabetes to improve glycemic control, announced AstraZeneca.

The new formulation of Bydureon is 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.

"The approval of BYDUREON BCise is clinically significant because it features a new formulation that provides the unique, continuous-release microsphere technology and powerful A1C reductions that physicians have come to expect from exenatide," Jim McDermott, PhD, Vice President of US Medical Affairs for Diabetes, AstraZeneca, told MD Magazine. "Now, the improved, easy-to-use device will help to enhance the patient experience with an injectable medicine, administered in 3 simple steps — mix, unlock, inject."

Bydureon BCise has a unique, continuous-release microsphere delivery system that’s designed to provide consistent therapeutic levels of exenatide to help patients reach and maintain a steady state, compared to other glucagon-like peptide-1 (GLP-1) receptor agonists.

The medication is administered in 3 simple steps: mix, unlock and inject, and is prefilled with a pre-attached hidden needle.

The new formulation is proven to reduce blood sugar levels and contribute to weight loss, however, 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 Bydureon BCise clinical trials include injection-site nodule (10.5%) and nausea (8.2%).

Bydueron BCise will be available for patients in the US in the first quarter of 2018. A regulatory application for the autoinjector device has also been accepted by the European Medicines Agency.

A press release has been made available.