Eli Lilly and Company, Amylin Pharmaceuticals and Alkermes announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Bydureon 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,exenatide 2 mg powder and solvent for prolonged release suspension, as a once-weekly dose to improve glycemic control in adults who have not achieved adequate glycemic control on maximally tolerated doses of oral therapies. If approved, Bydureon would be the first once-weekly type 2 diabetes treatment.
The CHMP’s positive opinion is now referred for final action by the European Commission, which has the authority to approve medicines for the European Union. The Commission usually makes a decision on CHMP recommendations within two to three months.
In the U.S., the New Drug Application for Bydureon (exenatide extended-release for injectable suspension) was submitted to the U.S. Food and Drug Administration (FDA) in 2009. The FDA issued a complete response letter and requested further data in late 2010. The companies plan to submit a response in the second half of 2011.