US FDA extends review of Amylin/Lilly's Byetta monotherapy application
This article was originally published in Scrip
Executive Summary
The US FDAis extending its review of the regulatory application forAmylin/Lilly's incretin mimetic Byetta (exenatide) injection as a monotherapy for treatment of patients with type 2 diabetes who are not achieving acceptable blood sugar control. The companies say that it is likely that the review may extend into 2009.