AstraZeneca says the European Commission has approved a new formulation of its once-weekly diabetes drug Bydureon.
According to the firm, Bydureon BCise (exenatide extended release) is an improved single-dose, pre-filled pen device that requires no titration.
It 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.
In the DURATION-NEO-1 trial, once-weekly Bydureon BCise showed an HbA1c reduction of 1.4% versus 1.0% for twice-daily Byetta (exenatide) injection at 28 weeks (baseline HbA1c 8.5% and 8.4%, respectively).
Bydureon BCise also 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,” said Elisabeth Björk, head of Cardiovascular, Renal and Metabolism, Global Medicines Development at AZ.