PHARMA/BIOTECH UPDATE: FDA rejects wider use of Feraheme, Amag’s anemia drug

Amag Pharmaceuticals released a statement today announcing that the US Food and Drug Administration (FDA) had issued a complete response letter for the supplemental new drug application (sNDA) of Feraheme (ferumoxytol) which is used to treat iron deficiency anemia (IDA) in adults that have unsuccessfully tried oral iron therapy.

A complete response letter is issued by the FDA when an application cannot be approved in its present form.  The FDA stated that Amag had not provided sufficient information to permit labeling of Feraheme for safe and effective use and indicated that its decision was based on cumulative freumoxytol data.

“The FDA did propose that the company conduct additional trials,” Amag Chief Executive William Heiden told Reuters. “We do have existing safety data from our two large late-stage trials … certainly we would look to that data to support the safety profile of Feraheme.”

“We continue to believe that approval of the Feraheme sNDA would provide physicians with an important treatment option for patients with IDA, who have failed or could not tolerate oral iron,” said Steve Caffé, M.D., chief development and regulatory officer of Amag Pharmaceuticals. “In the coming weeks, we intend to work with the FDA to determine the best regulatory path for Feraheme in this broader IDA patient population.”

From Amag’s press release:

About Feraheme® (ferumoxytol)/Rienso

In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have failed oral iron therapy. Feraheme received marketing approval from the U.S. Food and Drug Administration (FDA) on June 30, 2009 for the treatment of IDA in adult chronic kidney disease patients and was commercially launched by AMAG in the U.S. shortly thereafter.

Photo credit: Kaiser Permanente

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