StockMarketWire.com - AstraZeneca's easy-to-use injectable medicine for patients with type-2 diabetes has been approved by the US Food and Drug Administration.

AstraZeneca said the FDA had approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycaemic control.

AstraZeneca said that unlike other glucagon-like peptide-1 (GLP-1) receptor agonists, Bydureon BCise had a unique, continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state.

It said the new formulation in the innovative Bydureon BCise device was proven to reduce blood sugar levels, with the added benefit of weight loss.

It said: 'Across two clinical trials, average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds (1.4 kilograms) were achieved when used as monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of two of these oral anti-diabetic medicines at 28 weeks.

'The most common adverse reactions reported in ≥5% of patients in clinical trials were nausea (8.2%) and adverse events associated with injection-site nodules (10.5%).'






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