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FDA Rejects Expanded Labeling for Feraheme (Ferumoxytol)

Drug fails to win anemia indication (January 22)

The FDA has issued a complete response letter for the supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous (IV) use. The sNDA sought to expand the drug's use 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.

A complete response letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA stated that the drug’s developer (Amag Pharmaceuticals) did not provide sufficient information to permit the labeling of Feraheme for safe and effective use for the proposed indication. The FDA 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. In addition, the FDA proposed that the company evaluate alternative dosing and/or administration of Feraheme.

In the U.S., Feraheme (ferumoxytol) injection is indicated for the treatment of IDA in adult patients who have failed oral iron therapy. The drug received marketing approval on June 30, 2009 for the treatment of IDA in adult patients with CKD and was commercially launched in the U.S. shortly thereafter.

Source: Amag Pharmaceuticals; January 22, 2014.

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