AstraZeneca’s once-weekly auto-injector Bydureon BCise wins EU approval in type 2 diabetes

pharmafile | August 30, 2018 | News story | Research and Development, Sales and Marketing |  AstraZeneca, Bydureon, EU, Europe, diabetes, pharma, type 2 diabetes 

AstraZeneca has announced that its auto-injector Bydureon BCise (exenatide 2mg prolonged-release suspension) has been approved by the European Commission for the treatment of type 2 diabetes, an expansion of the existing authorisation for Bydureon.

This new formulation delivers via a once-weekly injection an improved single dose, requiring no titration and can be used alongside other glucose-lowering treatments such as basal insulin.

The EC’s decision was based on data derived from two clinical trials, wherein it reduced HbA1c levels by 1.4% after 28 weeks of use compared to Byetta (exenatide), another AZ therapy delivered twice-daily, which demonstrated reductions of just 1% in comparison. Additionally, Bydureon BCise reduced weight on average by 1.5kg as a monotherapy and 1.9kg when combined with oral antidiabetic medicines.  

Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development at AstraZeneca,explained: “Building on the already well-established efficacy and safety profile of once-weekly Bydureon, today’s approval of Bydureon BCise will enable us to offer an additional treatment option for patients with type-2 diabetes whose blood sugar levels are inadequately controlled by other glucose-lowering medicines together with diet and exercise.”

Matt Fellows