AMAG Pharmaceuticals (AMAG)

[surf1944]

8:47AM AMAG Pharma announces its European commercial partner, Takeda Pharmaceutical (TKPYY), has submitted a type-II variation to the European Medicines Agency for Rienso (ferumoxytol) (AMAG) 19.55 : Co announced that its European commercial partner, Takeda Pharmaceutical (TKPYY), has submitted a type-II variation to the European Medicines Agency for Rienso (ferumoxytol). The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia in adult patients with chronic kidney disease to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. 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."