Takeda looks to expand EU label for AMAG's Rienso

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) said partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) submitted a Type II variation application to expand the label of anemia drug Rienso ferumoxytol. Takeda is seeking approval for the drug to treat all adult patients with iron deficiency anemia who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. Takeda markets the IV iron replacement therapy in the EU, Switzerland, Canada and the U.S., where it is known as Feraheme, to treat iron deficiency anemia in chronic kidney disease (CKD). An sNDA is under review in the U.S. to expand the label for Feraheme to include the treatment of all adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment. The PDUFA date is Oct. 21. ...