AstraZeneca gets EC approval for Bydureon BCise

30th Aug 2018 07:23

(Sharecast News) - AstraZeneca announced on Thursday that 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 authorisation for Bydureon for the treatment of patients with type-2 diabetes.The FTSE 100 drugmaker said the new formulation of once-weekly Bydureon was an improved single-dose, pre-filled pen device that required no titration and was 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 were inadequately controlled by other glucose-lowering medicines together with diet and exercise.It said the approval was supported by data from two clinical trials - DURATION-NEO-1 and NEO-2.DURATION-NEO-1 was 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%, compared to 1.0% for twice-daily Byetta (exenatide) injection at 28 weeks.Additionally, Bydureon BCise demonstrated a mean weight reduction of -1.5 Kg as monotherapy compared to -1.9 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 AstraZeneca Global Medicines Development's head of cardiovascular, renal and metabolism Elisabeth Björk.The new formulation of once-weekly Bydureon BCise was approved by the US Food and Drug Administration in October last year.