FDA approves new Bydureon formulation, auto-injector

SILVER SPRING, Md. — The Food and Drug Administration has approved an auto-injector and new formulation of a once-weekly treatment for Type 2 diabetes from AstraZeneca. Bydureon BCise offers a single-dose auto-injector for adults with Type 2 diabetes whose blood sugar is uncontrolled on one or more oral medicines.

Bydureon BCise features a continuous-release delivery system that provides consistent levels of the product’s active ingredient, exenatide, to help patients maintain glycemic control, the company said. The new formulation in the Bydureon BCise device also has shown the ability to reduce blood sugar levels alongside weight loss, despite not being a weight loss medication.

“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,” AstraZeneca US president and EVP North America Ruud Dobber said. “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.”

The company plans to launch Bydureon BCise in the first quarter of 2018 while keeping the Bydureon pen available for patients.

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