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FDA demands REMS for Bydureon

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INDIANAPOLIS Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes encountered a speed bump in their efforts to win approval for a long-acting formulation of a Type 2 diabetes drug.

The three companies announced Monday that the Food and Drug Administration declined to approve their application for Bydureon, a once-weekly formulation of exenatide, the active ingredient of Byetta.

The FDA cited finalization of product labeling with accompanying risk evaluation and mitigation strategy, or REMS, and clarification of manufacturing processes as its reason for giving the companies a complete response letter for their approval application for the drug. A complete response letter from the FDA means that the review of an application is complete, but the drug is not ready for approval.

“This is a siginificant step forward in our ability to bring this important therapy to patients,” Amylin SVP research and development Orville Kolterman said. “We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks.”

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