AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced the completion of patient enrollment in the second of the company's two phase III studies that comprise its global registrational program for Feraheme® (ferumoxytol) in patients with iron-deficiency anemia (IDA) who are not candidates for oral iron, regardless of the underlying cause. The two phase III studies include one comparing treatment with Feraheme to placebo and one comparing treatment with Feraheme to treatment with intravenous iron sucrose. Both studies have now completed enrollment, with more than 1,400 patients enrolled through 210 study sites globally.
“The completion of enrollment in this program is an important step forward in AMAG's goal to expand Feraheme's reach to a much larger number of patients who suffer from IDA”
"The completion of enrollment in this program is an important step forward in AMAG's goal to expand Feraheme's reach to a much larger number of patients who suffer from IDA," said Lee F. Allen, M.D., Ph.D., executive vice president and chief medical officer of AMAG. "As we complete data collection and analysis over the next few months, the results of these studies will form the basis for global regulatory submissions, which will seek to expand the indication of Feraheme for the treatment of IDA beyond the current indication for adult patients with chronic kidney disease."
AMAG plans to submit a sNDA for the broader U.S. label for Feraheme to the U.S. Food and Drug Administration in the second half of 2012. AMAG's partner, Takeda Pharmaceutical Company, is responsible for all regulatory filings seeking the broad IDA indication for Feraheme in its licensed territories.
Source AMAG Pharmaceuticals, Inc.