Takeda Pharmaceutical Company, AMAG Pharmaceuticals' European commercial partner, has submitted a type-II variation to the European Medicines Agency (EMA) for label expansion of Rienso (ferumoxytol).
The approval will allow the use of Rienso in all adult iron deficiency anemia patients who cannot take oral iron, in addition to current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).
AMAG president and chief executive officer William Heiden said, "If approved for this indication, we believe that Rienso could provide a new treatment option for iron deficiency anemia patients who cannot tolerate or do not respond to oral iron therapy."
Data from a global phase III program that assessed ferumoxytol's use in a range of adult IDA patients is included in the submission.
Takeda Global Research and Development Centre (Europe) managing director Stuart Dollow said, "As part of Takeda's mission to discover and develop innovative solutions addressing the unmet medical needs of patients, we are pleased to be able to be able to work in partnership with AMAG to seek to extend the use of Rienso to provide greater patient benefit."
