LEXINGTON, Mass.—AMAG Pharmaceuticals submitted a marketing authorization application on June 1 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.
“We have thus far made great progress on our key objectives for this year,” said Brian J.G. Pereira, MD, President and CEO of AMAG Pharmaceuticals. “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.”
