Amylin announces positive results for exenatide study

Amylin Pharmaceuticals and partners Eli Lilly and Alkermes today announced positive results for their 30-week comparator study of once-weekly exenatide long-acting release (LAR) injection.

The study compared the once-weekly exenatide with a twice-daily regimen of the Byetta injection in patients with type two diabetes.

Results demonstrated that once-weekly exenatide showed a statistical superiority in glucose control compared to Byetta.

After 30 weeks, both treatments resulted in an average weight loss of approximately eight pounds.

Orville G Kolterman, senior vice president of clinical and regulatory affairs at Amylin Pharmaceuticals, commented: “These data confirm the benefits of Byetta as an important treatment option and suggest that, if approved, once-weekly exenatide has the potential to help patients improve their diabetes management.”

Patients not achieving adequate glucose control with either diet or exercise were enrolled on to the study and nearly 90 per cent of subjects completed it.

The companies plan to submit a New Drug Application Filing for once-weekly exenatide by the end of the first half of 2009.

Last year, Eli Lilly and Amylin announced that their Byetta treatment for type two diabetes had received marketing authorisation from the European commission.