30 August 2018 - AstraZeneca today announced that the European Commission has approved Bydureon BCise (exenatide 2 mg prolonged-release suspension for injection in pre-filled pen) as a new formulation within the marketing authorisation for Bydureon (exenatide extended release) for the treatment of patients with type-2 diabetes.
The new formulation of once-weekly Bydureon is an improved single-dose, pre-filled pen device that requires no titration and is approved for use in combination with other glucose-lowering medicines, including basal insulin, to help improve glycaemic control in adults with type 2 diabetes mellitus whose blood sugar levels are inadequately controlled by other glucose-lowering medicines together with diet and exercise.
This approval is supported by data from two clinical trials, DURATION-NEO-1 and NEO-2.
Read AstraZeneca press release