Advanced Magnetics ferumoxytol enters Phase III
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Advanced Magnetics anticipates submitting an NDA for its iron replacement therapy ferumoxytol for use in anemic chronic kidney disease (CKD), regardless of dialysis status, by the end of 2005. The firm has initiated two identical Phase III trials in anemic CKD patients not yet on dialysis; a Phase III study in anemic CKD patients on dialysis is slated to begin in the second-quarter. Advanced Magnetics anticipates the initiation of Phase III trials for use in magnetic resonance angiography before the end of 2004...