AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) and Takeda Pharmaceutical Company Limited (TSE: 4502) today provided a regulatory and clinical update for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.
“We have thus far made great progress on our key objectives for this year”
On June 1, 2010, AMAG submitted a marketing authorization application (MAA) for Feraheme for the treatment of iron deficiency anemia (IDA) in chronic kidney disease patients to the European Medicines Agency (EMA). The EMA has since notified AMAG that the submission has been validated for review.
The companies are also pleased to report that the global registrational program to expand the indication of Feraheme to include the treatment of IDA regardless of the underlying cause has been initiated. The program consists of two phase III studies - one 800 patient, double-blind, placebo-controlled study and the other a 600 patient open label, active-controlled study comparing ferumoxytol to IV iron sucrose. Both trials will evaluate changes in hemoglobin levels as well as other efficacy and safety endpoints. The program is now enrolling patients; the companies expect that it will take up to 18 months to complete enrollment.
"We have thus far made great progress on our key objectives for this year," said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. "With the MAA filing validated by the EMA and the global registrational program for Feraheme for the broader indication of the treatment of iron deficiency anemia underway, we are several steps closer to expanding the reach of Feraheme, both geographically and to new patient populations."
Dr. Erich Brunn, Chief Executive Officer, Takeda Pharmaceuticals Europe said: "For Takeda in Europe, this represents an important first step forward in our entry into a new therapeutic area. Feraheme has the potential to provide physicians in Europe with an important new approach in the treatment of patients with iron deficiency anemia."
AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited