LEXINGTON, Mass. (AP) — Amag Pharmaceuticals Inc. said Friday a European Union regulatory committee is recommending approval for its iron deficiency drug Feraheme.
The Committee for Medicinal Products for Human Use said Feraheme should be approved as a treatment for iron deficiency anemia in adult with chronic kidney disease, Amag said. The European Medicines Agency is not required to follow the recommendation, but it often does so. If the EMA approved the drug, Amag’s partner Takeda Pharmaceutical Co. will market it under the name Rienso.
Amag said it will get $30 million if the drug is approved and sales begin, and it will get royalty payments of more than 10 percent on sales. Takeda hopes to start selling the drug in the second half of 2012.
The Food and Drug Administration approved Feraheme in June 2009, and Canadian regulators approved the drug in December 2011.
Amag Pharmaceuticals shares rose 67 cents, or 4.4 percent, to $15.93 on Friday.