Rienso®▼ (ferumoxytol) Receives European Marketing Authorisation for the Treatment of Iron Deficiency Anaemia in Adult Chronic Kidney Disease Patients

LONDON, OSAKA, Japan and LEXINGTON, Massachusetts, June 22, 2012 /PRNewswire/ --

Takeda Pharmaceutical Company Limited (Takeda) and AMAG Pharmaceuticals, Inc. today announced the granting of marketing authorisation by the European Commission (EC) for ferumoxytol, a new intravenous (IV) iron therapy to treat iron deficiency anaemia (IDA) in adult patients with chronic kidney disease (CKD). The marketing authorisation follows a positive opinion issued on April 19, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). With receipt of the EC decision, Takeda intends to launch ferumoxytol across Europe in the near future.

"The granting of European marketing authorisation for ferumoxytol marks an important milestone for Takeda in our ongoing commitment to the field of renal medicine. We look forward to providing ferumoxytol, a valuable new therapeutic option, to clinicians in the near future" said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals.

The marketing authorisation, which will be held by Takeda Global Research & Development Centre (Europe) Ltd, is valid in the current EU Member States as well as in Iceland and Norway, and is based on data obtained from an extensive clinical development programme. Across the three pivotal Phase III safety and efficacy studies, 1,726 subjects were exposed to ferumoxytol, including 1,562 patients with all stages of CKD; in which ferumoxytol was administered as a rapid injection.^[1,2,3] From these studies, ferumoxytol significantly increased haemoglobin levels as compared to oral iron across the spectrum of CKD.^[1,2,3] Moreover, ferumoxytol was well tolerated by CKD patients with IDA and had a similar overall treatment-related adverse event rate to oral iron.^[1] These outcomes were further supported by additional retrospective observational data from three large haemodialysis clinics in the United States involving more than 8,600 patients and more than 33,300 administered doses of ferumoxytol.^[4,5]

Iron deficiency is a common cause of anaemia often seen in the later stages of CKD, as renal function deteriorates and erythropoiesis (red blood cell production) declines. IDA can have a profound impact on patients' lives, causing fatigue, shortness of breath and an increase in the risk of cardiovascular (CV) complications including congestive heart failure. ^[6,7]

"While treatments for iron deficiency anaemia have been widely available for many years, the disease continues to place a significant burden on the everyday life of CKD patients worldwide, and its management should be tailored to appropriately address the clinical consequences of this debilitating condition" says Francesco Locatelli, Scientific Director, Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy. "Ferumoxytol offers an effective and convenient alternative to current therapies in the management of anaemia, and news of its approval will be warmly received by the renal community".

Notes to Editors

About Rienso^® (ferumoxytol)  

Ferumoxytol is an IV iron therapy with an approved indication for the treatment of IDA in adult patients with CKD. The maximum total dose of ferumoxytol is 1020mg, which is administered as an initial 510mg intravenous injection, followed by a second 510mg intravenous injection 2-8 days later. The intended treatment course for most adults is two injections of 510mg intravenous iron. Ferumoxytol significantly increases Hb levels in CKD patients with IDA, both on dialysis and in patients not on dialysis compared with oral iron. Clinical trials have also highlighted that ferumoxytol is well tolerated.

Ferumoxytol was developed by AMAG Pharmaceuticals, Inc and is marketed outside the US by Takeda Pharmaceuticals following announcement of a comarketing agreement in March 2010. Ferumoxytol is currently approved for use in Canada and the US as Feraheme^®.

A Summary of Product Characteristics will be available on the EMA website shortly.

References

1. Spinowitz BS, Kausz AT, Baptista J, et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol 2008; 19: 1599-1605.
2. AMAG Pharmaceuticals. Data on file.
3. Provenzano R, Schiller B, Rao M, et al. Clin J Am Soc Nephrol 2009; 4: 386-393.  
4. Schiller B, Bhat P, Sharma A, et al. Safety of Feraheme^® (Ferumoxytol) in hemodialysis patients at 3 dialysis chains over a 1-year period. J Am Soc Nephrol 2011; 22: 477A-478A. Abstr FR-PO1573.
5. Sharma A, Bhat P, Schiller B, et al. Efficacy of Feraheme^® (Ferumoxytol) administration on target hemoglobin levels and other iron parameters across 3 dialysis chains. J Am Soc Nephrol 2011; 22: 485A. Abstr FR-PO1603.
6. O'Mara NB. Anemia in patients with chronic kidney disease. Diabetes Spectrum 2008; 21: 12-19.
7. National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006; 47:S11-15.

About Takeda Pharmaceuticals International GmbH

Takeda Pharmaceuticals International GmbH, headquartered in Zurich, is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. As the largest pharmaceutical company in Japan and a leader in the global industry, Takeda's mission is to strive toward better health for patients worldwide through leading innovation in medicine. It has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Takeda is ranked 12th by global Rx sales, 14th in the BRIC countries and 18th in Europe. Takeda's commercial presence mainly covers the therapeutic areas of metabolic diseases, gastroenterology, oncology, cardiovascular health, CNS diseases, inflammatory and immune disorders, respiratory diseases and pain management.