Pharmaceutical Business review

Amylin, Alkermes announce availability of Bydureon in US

Bydureon, once-weekly treatment for type 2 diabetes, was approved by FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The approval was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with Bydureon resulted in improvements in glycemic control in a once-weekly dose.

Bydureon is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous (under the skin) injection, the companies said.