AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Bydureon BCise.
The new formulation of Bydureon is 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.
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, an AstraZeneca release stated.
The new formulation in the innovative Bydureon BCise device is proven to reduce blood sugar levels, with the added benefit of weight loss.
Ruud Dobber, president, AstraZeneca US and executive vice president, North America, said: “We know that physicians have established long-standing confidence in the significant HbA1c reduction Bydureon provides their patients to help achieve consistent control, with the added benefit of weight loss. 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.”
Bydureon BCise will be available for patients in the US in the first quarter of 2018. A regulatory application for the new autoinjector device has also been accepted by the European Medicines Agency.
