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Analysis Shows BYDUREON™ Was Not Associated with Clinically Relevant QT Prolongation in Patients with Type 2 Diabetes: Results Presented at ADA 2011
Date:6/24/2011

focus our efforts on making this once-weekly therapy available to patients and healthcare providers in the U.S."

BYDUREON received marketing authorization in the European Union earlier this month. In the U.S., the FDA issued a complete response letter for the BYDUREON New Drug Application in late 2010. The companies plan to submit a response, including results of the thorough QT (tQT) study, in the second half of 2011. The tQT study uses intravenous exenatide to achieve plasma exenatide concentrations expected with BYDUREON, including the concentrations expected in patients with renal impairment.

BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension. It is an investigational medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which has been available in the U.S. since June 2005 and is used in more than 70 countries worldwide to improve glycemic control in adults with type 2 diabetes.

Analysis Design

This analysis included 148 patients with type 2 diabetes from the BYDUREON arm of DURATION-1, a phase 3, randomized, open-label, comparator-controlled trial. Electrocardiogram (ECG) recordings were performed at baseline; once steady-state plasma exenatide concentrations had been achieved following at least 14 weeks of treatment; and in a subset of patients at 30 weeks of treatment or sooner if the patient left the study early. Board-certified cardiologists who were blinded to treatment assignment performed analyses (interpretations) of all ECG tracings.

About Diabetes

Diabetes affects nearly 26 million people in the U.S. and an estimated 285 million adults worldwide.(ii, iii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs more than $174 billion per year in direc
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
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