European Commission approves new easy-to-use, once-weekly Bydureon BCise device for patients with type 2 diabetes mellitus

AstraZeneca

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


Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe