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news.AMAG Pharmaceuticals and Takeda Pharmaceutical have said that European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Feraheme (ferumoxytol) Injection for intravenous (IV) use.
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On June 1, 2010, AMAG had submitted MAA for Feraheme for the treatment of iron deficiency anemia (IDA) in chronic kidney disease patients.
AMAG has two partners for the development and commercialization of Feraheme outside of the US, 3SBio Inc to develop and commercialize Feraheme for CKD in China and Takeda Pharmaceutical to develop and commercialize Feraheme for all therapeutic applications in five ex-US regions, including Europe, Canada, Turkey, the Commonwealth of Independent States and several Asia Pacific countries.
AMAG has exclusive rights to commercialize Feraheme in the US and certain ex-US territories.
AMAG and Takeda have also begun the global registrational program, to expand the indication of Feraheme to include the treatment of IDA regardless of the underlying cause.
The program consists of two Phase III studies. The first study is a double-blind, placebo-controlled study evaluating 800 patient, whereas the other trial is an open label, active-controlled study comparing ferumoxytol to IV iron sucrose is evaluating 600 patients.
Brian Pereira, president and CEO of AMAG Pharma, said: “We have thus far made great progress on our key objectives for this year. 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.”
Erich Brunn, CEO of 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.”