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ESAs in Renal Disease: Amgen Braves an Advisory Committee Storm With Another Regulator in Mind

This article was originally published in RPM Report

Executive Summary

An FDA panel was convened to re-evaluate the cardiovascular risks associated with Amgen’s Aranesp and the ESAs after a third clinical trial showed CV endpoints going in a negative direction. The company was able to emerge from the meeting with a near-best case scenario. That’s critical with a CMS coverage decision looming.
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