AstraZeneca announced the European Commission (EC) has approved Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) as a new formulation within the marketing authorization 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 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, randomized, 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.

"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," Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development at AstraZeneca, said.

This new formulation of once-weekly Bydureon BCise was approved by the US Food and Drug Administration (FDA) in October 2017.

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