FDA News

FDA approves once-weekly exenatide extended-release injection

The FDA recently approved AstraZeneca’s GLP-1 receptor agonist exenatide extended-release injection in a once-weekly single-dose autoinjector device for the treatment of adults with type 2 diabetes, according to a press release from AstraZeneca.

The exenatide extended-release injection (Bydureon BCise) is a new formulation of the current exenatide extended-release injection (Bydureon). The new formulation has a continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the drug and has been shown to reduce blood sugar levels and promote weight loss, according to the release.

Approval for the injection was based on results from two clinical trials in which adults with type 2 diabetes experienced an average HbA1c reduction of up to 1.4% and an average weight loss of up to 3.1 pounds when exenatide was used as a monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of the two at 28 weeks. The most common adverse events were associated with injection-site nodules and nausea. The injection comes in a prefilled device with an attached hidden needle.

“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 US and executive vice president of AstraZeneca North America, said in the release. “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 new injection with be available in the United States in the first quarter of 2018.

The FDA recently approved AstraZeneca’s GLP-1 receptor agonist exenatide extended-release injection in a once-weekly single-dose autoinjector device for the treatment of adults with type 2 diabetes, according to a press release from AstraZeneca.

The exenatide extended-release injection (Bydureon BCise) is a new formulation of the current exenatide extended-release injection (Bydureon). The new formulation has a continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the drug and has been shown to reduce blood sugar levels and promote weight loss, according to the release.

Approval for the injection was based on results from two clinical trials in which adults with type 2 diabetes experienced an average HbA1c reduction of up to 1.4% and an average weight loss of up to 3.1 pounds when exenatide was used as a monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of the two at 28 weeks. The most common adverse events were associated with injection-site nodules and nausea. The injection comes in a prefilled device with an attached hidden needle.

“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 US and executive vice president of AstraZeneca North America, said in the release. “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 new injection with be available in the United States in the first quarter of 2018.