Exenatide is the first medicine in a new class of treatments known as incretin mimetics.
If approved, this new medicine for type 2 diabetes is planned to be marketed throughout the European Union 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 from current treatments.
“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,” said Lorenzo Tallarigo, president international operations at Lilly. ”
The submission package to support the safety and efficacy profile of Byetta consisted of data collected from 35 studies of patients with type 2 diabetes treated with exenatide. Three of the studies showed that exenatide can control blood sugar as effectively as insulin. Most patients in the exenatide clinical studies also experienced significant reductions in weight.