Amylin Pharmaceuticals, Inc and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) is continuing with its review of the regulatory application for use of Byetta (exenatide) injection as stand-alone therapy (monotherapy) in people with type-2 diabetes who are not achieving acceptable blood sugar control. It is likely that this review will not be complete by the end of 2008, and may extend into 2009.
"Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission," said Orville G Kolterman, senior vice president of research and development at Amylin Pharmaceuticals. "Importantly, we have not received any request for additional studies. We look forward to working closely with the agency as needed throughout the review process."
The regulatory application for use of Byetta as monotherapy was submitted in the first quarter of 2008. The FDA is also reviewing several other Byetta prescribing information updates submitted by the companies, including revision of safety language and conversion of physician labelling to the new standard format.
Byetta is the first and only FDA-approved incretin mimetic for the treatment of type-2 diabetes. Byetta exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1).