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AMAG Pharmaceuticals Announces Submission Of A Type II Variation For Rienso Label Expansion In Europe To Include All Adult Iron Deficiency Anemia Patients Who Cannot Take Oral Iron

Stocks in this article: AMAG

LEXINGTON, Mass., June 7, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that its European commercial partner, Takeda Pharmaceutical Company Limited, has submitted a type-II variation to the European Medicines Agency (EMA) for Rienso® (ferumoxytol). The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used.

"The filing of the type-II variation for the broad IDA indication for Rienso marks an important corporate milestone for AMAG," said William Heiden, president and chief executive officer of AMAG. "If approved for this indication, we believe that Rienso could provide a new treatment option for iron deficiency anemia patients who cannot tolerate or do not respond to oral iron therapy."

The EMA submission is comprised of data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom either did not achieve satisfactory results from or could not tolerate oral iron treatment. More than 1,400 patients were enrolled in the phase III studies, IDA-301 (placebo comparator) and IDA-302 (active comparator). Patients enrolled in IDA-301 were also eligible to participate in IDA-303, an extension study to evaluate repeat dosing with ferumoxytol. The data from these studies have previously been reported (see AMAG press releases dated December 10, 2012 and March 15, 2013 for more information).

 "As part of Takeda's mission to discover and develop innovative solutions addressing the unmet medical needs of patients, we are pleased to be able to be able to work in partnership with AMAG to seek to extend the use of Rienso to provide greater patient benefit," said Stuart Dollow, managing director of Takeda Global Research and Development Centre (Europe) Ltd.

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