BYDUREON Recommended For Approval In Europe (LLY, ALKS)

Eli Lilly and Company LLY, together with Amylin Pharmaceuticals, Inc. AMLN and Alkermes, Inc. ALKS, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of exenatide 2 mg powder and solvent for prolonged release suspension for injection in the European Union for the treatment of type 2 diabetes in combination with certain oral therapies. This application to the European regulatory authorities is for use of BYDUREON as a once-weekly 2 mg dose to improve glycemic control in adults who have not achieved adequate glycemic control on maximally tolerated doses of these oral therapies. If approved, BYDUREON would be the first once-weekly type 2 diabetes treatment.