Agency asked to finalize labeling and manufacturing processes for once-weekly version of Byetta to be called Bydureon.
Amylin Pharmaceuticals, Eli Lilly, and Alkermes reported that the FDA has issued a complete response letter regarding the NDA for exenatide extended-release injectable suspension as a treatment for type 2 diabetes. Bydureon is the proposed brand name for exenatide once weekly.
In the complete response letter there are no requests for new preclinical or clinical trials, according to the companies. Issues raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes, they explain. The complete response letter reportedly does not contain requests related to the December 2009 observations from the FDA’s preapproval inspection at the Ohio manufacturing facility. All those observations have been addressed, the firms note.
“We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks,” says Orville G. Kolterman, M.D., svp of R&D, Amylin.
Bydureon is designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. It belongs to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.