AstraZeneca (NYSE:AZN) said today that the FDA approved its once-weekly exenatide drug in a single-dose auto-injector for adults with Type II diabetes whose blood sugar is uncontrolled on one or more oral drugs.
The company’s drug, Bydureon, is formulated with a continuous-release microsphere delivery system designed to provide consistent levels of exenatide, according to AstraZeneca, to reduce blood sugar levels in people with diabetes.
When used as a monotherapy or as an add-on to an array of oral anti-diabetic medications, people who used the drug experienced average HbA1C reductions of up to 1.4% and an average weight loss of up to 3.1 pounds after 28 weeks, according to data from two clinical trials.
The auto-injector features a pre-attached hidden needle and allows for administration in three steps: mix, unlock and inject.
“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,” Ruud Dobber, president of AstraZeneca’s North America operations, said in prepared remarks. “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 drug-device combo is slated to be available for patients in the U.S. in the first quarter of next year. A regulatory application for the autoinjector device has also been accepted by the European Medicines Agency, AstraZeneca reported.