The trial is the second of the company’s two phase III studies that comprise its global registrational program for Feraheme (ferumoxytol).
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 completed enrollment, with more than 1,400 patients enrolled through 210 study sites globally, the company said.
AMAG chief medical officer Lee Allen said the results of these studies will form the basis for global regulatory submissions, which will seek to expand the indication of Feraheme.