FDA okays unique injectable for type 2 diabetics

FDA approved a new once-weekly, single-dose autoinjector device to improve glycemic control in adults with type 2 diabetes.

Related: FDA approves 2 injectable diabetes drugs

The agency okayed Bydureon BCise injectable suspension (AstraZeneca), a new formulation of Bydureon, which will be available in the first quarter of 2018.

The price of Bydureon BCise “will remain at parity with the current list price for Bydureon Pen,” AstraZeneca said in a statement provided to FormularyWatch. “When making any pricing decision, we aim to price responsibly and in line with current treatment costs where treatment options exist; this determination starts and ends with the patient.”

Related: New diabetes drug enters competitive market

Unlike other glucagon-like peptide-1 (GLP-1) receptor agonists, Bydureon BCise has 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, according to the statement.

“The new formulation in the innovative Bydureon BCise device is proven to reduce blood sugar levels, with the added benefit of weight loss,” the statement said.

Across 2 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 2 of these oral anti-diabetic drugs at 28 weeks.

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