Amag Pharmaceuticals Inc. said Wednesday that a late-stage clinical trial showed its drug Feraheme worked better than a placebo as a treatment for anemia with any cause.
Amag said Feraheme was more effective than a placebo at increasing the hemoglobin levels of patients after five weeks of treatment. Patients who took the drug were also more likely to have a significant increase in hemoglobin levels at any point in the trial. Feraheme was approved in 2009 as a treatment for anemia caused by chronic kidney disease, and Amag wants to market the drug as a treatment for anemia with any cause.
The company said in March that Feraheme worked better than intravenous sucrose in a separate clinical trial. Both studies involved patients who either were not helped by oral iron drugs or who could not take those products. Amag plans to ask the Food and Drug Administration for the additional marketing approval by the end of 2012, and it expects the FDA to make a decision in late 2013.
Shares of Amag rose 35 cents, or 2.2 percent, to $16.20 in morning trading.
Patients in the trial had anemia associated with conditions like cancer, gastrointestinal disease, and uterine bleeding. Amag said the most common side effects of Feraheme included low blood pressure and hypersensitivity reactions, and no new side effects were observed during the trial.
The FDA approved Feraheme in June 2009. European Union regulators approved the drug on June 22 under the name Rienso as a treatment for anemia associated with chronic kidney disease. Amag expects $53 million to $57 million in revenue from Feraheme in 2012.