FDA review of wider Byetta label delayed

US drugmaker Amylin Pharmaceuticals and its partner, drug major Eli Lilly, say that the Food and Drug Administration's review of an extended label for Byetta (exenatide) may take longer than expected.

The agency is considering approving the injection as stand-alone therapy for type 2 diabetes patients who are not achieving acceptable blood sugar control. It is likely that a decision will not be reached by the end of 2008, and may extend into 2009, the firms noted.

"Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission," said Orville Kolterman, senior vice president of R&D at Amylin. "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," he added.