BRIEF—New formulation of diabetes product approved in the USA

The UK’s AstraZeneca has received US FDA approval for Bydureon BCise (exenatide extended-release), a new once-weekly, single-dose autoinjector-based formulation of Bydureon.

The product is approved for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise.

The application was supported by data from clinical trials showing average reductions of glycated hemoglobin (HbA1c) of up to 1.4% and average weight loss of up to 1.4 kilograms.

The company says it will start selling the product in the USA in the first quarter of 2018. The European Medicines Agency is also reviewing a regulatory submission for the product.