US regulators have given the thumbs-up to AstraZeneca’s pre-filled, single-use pen injector version of its long-acting diabetes drug Bydureon.
The US Food and Drug Administration has approved the Bydureon Pen (exenatide extended-release) as a once-weekly adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. It eliminates the need for the patient to transfer the medication between a vial and syringe during the self-injection process and contains the same formulation and dose as the original Bydureon single-dose tray; the latter, a glucagon-like peptide-1 (GLP-1) receptor agonist, was approved by the FDA in 2012.
Chief medical officer Briggs Morrison said the Bydureon Pen 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”. It can be administered at any time of the day, with or without meals.
AstraZeneca added that it plans to make the pen available in the USA later this year. The Bydureon single-dose tray will still remain on the market but the much more convenient pen injector should boost the drug’s position in the GLP-1 arena.
