AMAG Pharmaceuticals, Inc.'s 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 anaemia (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 anaemia patients who cannot tolerate or do not respond to oral iron therapy."
The EMA submission is comprised of data from a global phase III programme 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.
In the United States, Feraheme (ferumoxytol) Injection for IV use is indicated for the treatment of iron deficiency anemia in adult CKD patients. Feraheme received marketing approval from the FDA on June 30, 2009 and was commercially launched by AMAG in the US shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso.
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme in the United States.