AstraZeneca announced that the US Food and Drug Administration (FDA) has approved the Bydureon Pen for adults with type 2 diabetes. Bydureon had already been approved for use in a syringe, with the patient transferring the drug from a vial.
Bydureon Pen is the once-weekly medicine for adults with type 2 diabetes. The Bydureon Pen is a pre-filled, single-use pen injector. The Pen contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release.
The drug is part of a portfolio AstraZeneca acquired from a joint venture between Bristol Myers Squibb and AZ. The company has administrative offices and a manufacturing presence in northern Delaware.
Bydureon has been shown to provide blood glucose level reduction. Additionally, Bydureon patients saw some weight loss. The drug is not recommended for obesity control and the weight loss was a secondary finding in trials.
“We’re pleased to receive approval for the Bydureon Pen, which can provide a powerful reduction in blood glucose levels along with the potential benefit of weight loss, through a once-weekly dose in a pre-filled device,” said Briggs Morrison, chief medical officer, AstraZeneca. “We are committed to addressing the needs of adults with type 2 diabetes, including ongoing research to develop new treatments and methods of delivery.”
AstraZeneca plans to make the Bydureon Pen available for patients in the US later this year. The current tray will remain on the market in the US for some patients who had been prescribed the drug.
The FDA approval for Bydureon was received in 2012. It is available in 42 countries worldwide, including European Union countries.
