Bydureon, an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose, is the proposed brand name for exenatide once weekly.
Bydureon NDA was submitted in May 2009 and is based on data that include the Duration-1 head-to-head clinical study, safety data from Duration-2 and more than seven years of clinical experience with Byetta.
A thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of Bydureon was requested by the FDA in thecomplete response letter.
Additionally, the FDA has now requested the results of the Duration-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of Bydureon.
Amylin, Lilly and Alkermes said that their goal is to submit their reply to the complete response letter by the end of 2011, pending discussions with the FDA.
Amylin Pharmaceuticals senior vice president and chief medical officer Orville Kolterman said that they were committed to working closely with the FDA to resolve the issues raised in the complete response letter so that Bydureon can be approved.
The agency issued a complete response letter to the companies in March 2010 and in May 2010 classified the companies’ first complete response as a Class 2 resubmission with a PDUFA action date of 22 October 2010.