Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Eli Lilly, Amylin Pharma and Alkermes have received complete response letter from FDA regarding the new drug application (NDA) for Bydureon (exenatide for extended-release injectable suspension).
Subscribe to our email newsletter
Bydureon is the proposed brand name for Exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of Exenatide in a single weekly dose.
Bydureon has been available in the US since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. Bydureon and Byetta belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.
In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalisation of the product labeling with accompanying risk rvaluation and mitigation strategy (REMS) and clarification of existing manufacturing processes.
Additionally, the complete response letter does not contain requests related to the December 2009 observations from the FDA’s pre-approval inspection at the Ohio manufacturing facility. All of those observations have been addressed.
The NDA for Bydureon was submitted in May 2009 and accepted by the FDA in July 2009. It is based on data from the Duration clinical trial program, as well as more than seven years of clinical experience with Byetta.
Orville Kolterman, senior vice president of research and development at Amylin, said: “This is a significant step forward in our ability to bring this important therapy to patients. We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks.”