FDA Approves Weekly Diabetes Injectable
Patients treated with Bydureon BCise had an average HbA1c reduction of 1.4% after 28 weeks.
AstraZeneca announced yesterday that the FDA has approved Bydureon BCise (exenatide extended-release), a weekly auto-injector for patients with type 2 diabetes whose blood glucose levels are uncontrolled despite oral medications, diet, and exercise, according to a press release.
Bydureon BCise is a continuous-release glucagon-like peptide-1 (GLP-1) receptor agonist. The drug’s microsphere delivery system ensures that patients receive a consistent level of exenatide for optimal blood glucose control, AstraZeneca reported.
Additionally, the newly-approved drug can also help patients with type 2 diabetes lose weight, which may further help blood glucose control.
In clinical trials, patients treated with Bydureon BCise had an average HbA1c reduction of 1.4% and weight loss of up to 3.1 pounds, according to the release. These results were achieved when the drug was used as a monotherapy or in combination with metformin, a sulfonylurea, a thiazolidinedione, or a combination of the drugs.
Common side effects included nausea and injection site nodules, according to the release.
AstraZeneca advises that patients should not use the drug as a first-line therapy and it should be used in addition to diet and exercise.
AstraZeneca reports that Bydureon BCise will be available for patients in 2018. An application for the injectable has also been accepted by the European Medicines Agency.
“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,” said Ruud Dobber, president, AstraZeneca US and executive vice president, North America. “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.”