* Company to submit for FDA approval by end of 2012
* Study meets main goals set by U.S., EU regulators
July 18 (Reuters) - Amag Pharmaceuticals Inc said its drug Feraheme met the main goal of improving hemoglobin levels in anemia patients in a late-stage study, clearing it to be pitched for approval in the United States and Europe for a wider indication.
The drug, which is already approved for the treatment of iron deficiency anemia in chronic kidney disease patients, is being tested as a treatment for iron deficiency anemia regardless of the underlying cause.
“With both phase III studies in our global registrational program for Feraheme now complete, we will seek approval for Feraheme for the treatment of a broader population of patients,” Lee Allen, Amag’s chief medical officer, said in a statement.
The company plans to submit a marketing application for the U.S. approval of Feraheme for the expanded indication by the end of this year. Partner Takeda Pharmaceutical Co Ltd plans to file for approval in Europe next year, it added.
Patients on Feraheme showed a statistically significant increase in hemoglobin level, compared with those on placebo, Amag said.
The late-stage study, which tested the efficacy of Feraheme on 808 patients across United States, Canada, India, Latvia, Hungary and Poland, met the targets set by U.S. and EU health regulators.
Amag said there were three deaths reported during the second late-stage study. Two of them were in the Feraheme-controlled group, but none related to the drug.
These results follow data released in March from another successful pivotal trial testing the drug on 605 patients at 74 sites in Europe, Asia Pacific and Australia.
Amag’s plan to stop searching for a buyer and focus resources on development of Feraheme was not taken well by investors in May even as it allowed its largest shareholder Adage Capital to raise its stake to up to 25 percent.
In line with that plan, the single-product company sold a plant and stopped production of an imaging agent in June.
Shares of the Lexington, Massachusetts-based company were up 1.7 percent at $16.12 in late-morning trade on Wednesday on the Nasdaq.