AstraZeneca cleared to market Bydureon BCise

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WILMINGTON, Del. — Early next year, AstraZeneca plans to release Bydureon BCise, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector for adults with type 2 diabetes.

The company said this week that it has received Food and Drug Administration approval for Bydureon BCise, indicated to improve glycemic control in type 2 diabetes patients whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise.

Bydureon BCise is designed to be more convenient and easy to use for patients via in a once-per-week, prefilled device with a preattached hidden needle, according to AstraZeneca. The medication is administered in three steps: mix, unlock and inject.

Unlike other glucagon-like peptide-1 (GLP-1) receptor agonists, Bydureon BCise has a unique, continuous-release microsphere delivery system to provide consistent therapeutic levels of exenatide, helping patients reach and maintain steady state, AstraZeneca reported. The company said new formulation in the device is proven to lower blood sugar levels with the added benefit of weight loss, although it’s not a weight loss medicine.

Plans call for Bydureon BCise to ship to U.S. pharmacies in the US in the first quarter of 2018. The Bydureon Pen will also remain available for patients, AstraZeneca said, adding that a regulatory application for the new autoinjector device has also been accepted by the European Medicines Agency.

“We know that physicians have established longstanding confidence in the significant HbA1c reduction Bydureon provides their patients to help achieve consistent control, with the added benefit of weight loss,” stated Ruud Dobber, president of AstraZeneca US and executive vice president of North America for AstraZeneca. “With the approval of Bydureon BCise, we’re now introducing a new formulation in an improved, easy-to-use device that will help enhance the patient experience.”


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