AstraZeneca announced that the EC has approved Bydureon BCise as a new formulation within the marketing authorisation for Bydureon 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 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. DURATION-NEO-1 is a 28-week, randomised, open-label, comparator-controlled trial (n=375), which showed that once-weekly Bydureon BCise demonstrated an HbA1c reduction of 1.4% vs. 1.0% for twice-daily Byetta (exenatide) injection at 28 weeks (baseline HbA1c 8.5% and 8.4%, respectively). Additionally, Bydureon BCise demonstrated a mean weight reduction of -1.5 Kg as monotherapy vs. -1.9 Kg (baseline was 97 Kg) when combined with certain oral antidiabetic medicines.
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development at AstraZeneca, said: “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.”
About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)
Cardiovascular, renal and metabolism together forms one of AstraZeneca’s main therapy areas and key growth drivers. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
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