AMAG Pharmaceuticals Inc. (AMAG) announced Wednesday that the U.S. Food and Drug Administration or FDA has issued a complete response letter for the supplemental new drug application or sNDA for Feraheme or ferumoxytol injection for intravenous or IV use.
The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment.
In the letter, the FDA stated that AMAG has not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed indication. The FDA also indicated that its decision was based on the cumulative ferumoxytol data, including the global phase III IDA program and global post-marketing safety reports.
The FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death.
Additionally, the FDA proposed potentially evaluating alternative dosing and/or administration of Feraheme.
AMAG said it is assessing the content and recommendations of the letter and plans further discussions with the FDA.
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