Kidney Disease

Phase III program for ferumoxytol modified in IV iron replacement therapy

Published in Drug Week, September 9th, 2005

Advanced Magnetics, Inc., (AVM) announced that after a recent meeting with the U.S. Food and Drug Administration (FDA) to evaluate its phase III development program for ferumoxytol in IV iron replacement therapy, the company plans to revise the program to include a new primary efficacy analysis suggested by the FDA.

The revised efficacy analysis is consistent with the analysis upon which a recent approval of another IV iron product was based. These modifications will result in additional patients being enrolled in the ferumoxytol chronic kidney disease (CKD) efficacy studies and will involve the re-design of the hemodialysis protocol currently under way.

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Source: Drug Week (2005-09-09)

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