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Green light for AstraZeneca’s Bydureon Pen
The FDA has approved the Bydureon Pen as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.
The pen is a pre-filled, single-use pen injector, eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process. It contains the same formulation and dose as the original Bydureon single-dose tray. “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, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca, in a press release. “We are committed to addressing the needs of adults with type 2 diabetes, including ongoing research to develop new treatments and methods of delivery.”
The company further announces that it has plans to make the Bydureon Pen available for patients in the US later this year. The Bydureon single-dose tray will remain on the market in the US for patients prescribed Bydureon. The FDA approval for Bydureon was received in 2012. Bydureon is currently available in 42 countries worldwide, including European Union countries.
Published: March 3, 2014
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