The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AMAG Pharmaceuticals' ferumoxytol, an iron deficiency anemia (IDA) therapy.
The intravenous (IV) iron therapy, indicated for the treatment of IDA in adult patients with chronic kidney disease (CKD), will be marketed as Rienso in the European Union by AMAG's partner, Takeda Pharmaceutical Company.
Takeda anticipates to launch the product in the second half of 2012, once it receives the European approval.
AMAG interim president and chief executive officer Frank Thomas said the European approval would mark the third region where ferumoxytol would be available for the treatment of iron deficiency anemia in patients with CKD.
"Continued growth in our U.S. CKD business, coupled with geographic expansion and the opportunity to further expand the product's label to include all patients with IDA, would significantly enhance the growth prospects for ferumoxytol," Thomas added.
AMAG would receive a $30m milestone payment from Takeda upon the European approval and the subsequent first commercial sale of ferumoxytol.
AMAG is also eligible to receive tiered, double-digit royalties on sales of ferumoxytol in licensed territories.
