Bydureon BCise Gets FDA Approval for Type 2 Diabetes
The Food and Drug Administration has approved Bydureon BCise (exenatide extended-release injectable suspension; AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
This new formulation of Bydureon (exenatide extended-release) allows for once-weekly administration because of its continuous-release microsphere delivery system designed to provide consistent therapeutic levels of exenatide. As the product is intended for self-administration, clinicians should train patients on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered.
In clinical trials, treatment with Bydureon BCise resulted in average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds when used as monotherapy or as an add-on to metormin, a sulfonylurea, a thiazolidinedione, or any combination of two of these agents, at 28 weeks.
Prior treatment with an immediate- or extended-release exenatide product is not required when initiating Bydureon BCise. Patients should discontinue treatment with other exenatide products before starting treatment.
Bydureon BCise, a glucagon-like peptide-1 (GLP-1) receptor agonist, is supplied as 2mg of exenatide per 0.85mL suspension in a pre-filled disposable single-dose autoinjector. It is expected to be available in the first quarter of 2018.
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