Long-acting exenatide data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lilly and Amylin announce data Aug. 22 from a 45-patient Phase II study of a long-acting release (LAR) formulation of the incretin mimetic Byetta (exenatide) in type 2 diabetes using Alkermes' Medisorb injectable extended-release delivery technology. Patients in the 15-week study were randomized to one of two once-weekly doses of exenatide LAR or placebo. HbA1C "improved approximately 2% for subjects receiving the high dose of exenatide LAR compared to placebo," Amylin says; baseline A1C in the study was 8.5%. Fasting blood glucose concentrations decreased approximately 50 mg/dL in the high dose group vs. placebo, the firm reports. FDA approved immediate-release Byetta on April 28 for twice-daily dosing (1Pharmaceutical Approvals Monthly May 2005, p. 20)...