AMAG Pharmaceuticals Announces Head-to-Head Phase 3 Clinical Trial Evaluating Feraheme(R) in Adults With Iron Deficiency Anemia

AMAG Pharmaceuticals, Inc.

today announced that it has commenced start-up activities for its head-to-head Phase 3 clinical trial evaluating the safety of Feraheme(R) (ferumoxytol) compared to Injectafer(R) (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA). The planned safety trial follows the Complete Response Letter (CRL) AMAG received from the U.S. Food and Drug Administration (FDA) in January 2014 regarding its supplemental new drug application (sNDA) to broaden the use of Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment. "We have worked closely with the FDA to develop a path forward for potentially broadening the indication for Feraheme to include all patients with iron deficiency anemia. This safety trial represents a significant step forward in that process," said Dr. Julie Krop, chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. "Approximately 4.5 million Americans suffer from the debilitating effects of IDA, and we believe healthcare providers need additional treatment options to help care for their IDA patients." The randomized, double-blind, multicenter non-inferiority trial will evaluate the incidence of moderate to severe hypersensitivity reactions (including anaphylaxis), and moderate to severe hypotension with Feraheme compared to ferric carboxymaltose injection in adults with IDA. Two thousand patients will be randomized in a 1:1 ratio into one of two treatment groups -- 1.02 grams of Feraheme intravenous (IV) infusion or 1.5 grams of ferric carboxymaltose injection. While the trial's primary endpoint is safety, the study will also assess efficacy. "Moving forward with this head-to-head clinical trial to support potential FDA regulatory approval for a broader indication of Feraheme highlights our commitment to not only the IDA community but also to maternal health," said William Heiden, chief executive officer of AMAG. "Today, 1.5 million of the 4.5 million Americans already diagnosed with IDA are women with abnormal uterine bleeding, or who are pregnant or post-partum. Many of these women are under the care of the obstetricians who are called upon by our maternal health commercial team. We believe an expanded indication would allow us to help these women, as well as other patients whose IDA has not been successfully treated with oral iron." AMAG expects to begin enrolling patients in the trial in the first quarter of 2016, with a potential sNDA approval and launch in 2018.