The European Commission has granted Amylin Pharmaceuticals and Eli Lilly marketing authorization for Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin for the treatment of type 2 diabetes (T2D).
The authorization provides a new option for the many patients with T2D who are not achieving adequate glycemic control with metformin or Actos (pioglitazone).
The main study included in the European marketing authorization submission package was a double-blind, 30-week clinical trial in which 10 micrograms of Byetta or placebo were added to existing insulin glargine therapy (with or without metformin, pioglitazone or both), which was titrated to achieve target fasting glucose levels. Results from the study demonstrated that Byetta significantly reduced A1C numbers compared to placebo. Patients who added Byetta to their insulin glargine regimen also saw their weight decrease by an average of 4 pounds.
Byetta will be marketed outside the U.S. by both Lilly and Amylin until the latter assumes complete responsibility once the pair’s decade-long collaboration dissolves. Amylin anticipates working with one or more partners outside the U.S. in order to maximize the global potential of the molecule and achieve greater operational flexibility and efficiency.