Eli Lilly and Company and Amylin Pharmaceuticals, Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of exenatide for the treatment of type 2 diabetes. If approved, this new medicine for type 2 diabetes is planned to be marketed throughout the EU under the proposed brand name Byetta. Marketing authorization by the European Commission is expected later this year. Amylin and Lilly are seeking approval of exenatide as an adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control on metformin and/or sulfonylurea, two common oral diabetes medications.

"Exenatide is an exciting treatment option for patients with type 2 diabetes who cannot control their blood sugar level effectively using the common oral medications metformin or sulfonylurea," said Lorenzo Tallarigo, president international operations at Lilly. "It also marks an important milestone for Amylin and Lilly in the fight against the worldwide diabetes epidemic."

"We are extremely pleased by the CHMP's recommendation for approval of exenatide in Europe. This positive opinion validates the benefit to risk profile seen in clinical trials for this new class of antidiabetic agents," said James Malone, MD, global medical director at Lilly. "Exenatide is another example of our commitment to provide innovative treatments for patients with diabetes."

The submission package to support the safety and efficacy profile of BYETTA consisted of data collected from 35 studies and included nearly 4,000 patients with type 2 diabetes treated with exenatide across more than 20 countries. Three of the studies compared exenatide to insulin and showed that exenatide can control blood sugar as effectively as insulin.(1, 2, 3) most patients in the exenatide clinical studies also experienced significant reductions in weight.