CHMP recommends change of approval for Bydureon (exenatide extended-release) in type-2 diabetes.- AstraZeneca.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Bydureon (exenatide extended-release), from AstraZeneca , in patients with type-2 diabetes. The CHMP adopted a change to the existing indication to extend the use of Bydureon in combination with insulin as follows: “Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products, including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations).”