Launch of Rienso® ▼ (Ferumoxytol) Offers Adult Patients with Chronic Kidney Disease a New Option for the Treatment of Iron Deficiency Anaemia

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Launch of Rienso® ▼ (Ferumoxytol) Offers Adult Patients with Chronic Kidney Disease a New Option for the Treatment of Iron Deficiency Anaemia PR Newswire ZURICH, November 1, 2012 ZURICH, November 1, 2012 /PRNewswire/ -- ®Today, Takeda Pharmaceuticals International GmbH (Takeda) announced the launch of Rienso (ferumoxytol) in the UK, a new intravenous (IV) iron therapy to treat iron deficiency anaemia (IDA) in adult patients with chronic kidney disease (CKD). This follows marketing authorisation granted by the European Commission (EC) in June 2012. Clinical studies demonstrated that Rienso significantly increases haemoglobin levels as compared to oral iron across [1],[2],[3]the spectrum of CKD. Moreover, Rienso was well tolerated by CKD patients with IDA and had an overall treatment-related adverse event rate similar to oral iron treatment based on data from three pivotal Phase III studies [1],[2],[3]involving 1,726 subjects. These outcomes were further supported by additional retrospective observational data from three large haemodialysis studies conducted in the United States involving more than 8,600 patients and more [4],[5]than 33,300 administered doses of Rienso.

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• Publié par: Takeda-UK-Ltd
• Nombre de lectures: 16
• Langue: English

Extrait

Launch of Rienso®▼(Ferumoxytol) Offers Adult Patients with Chronic Kidney Disease a New Option for the Treatment of Iron Deficiency Anaemia

PR Newswire ZURICH, November 1, 2012

ZURICH,November 1, 2012/PRNewswire/ --

® Today, Takeda Pharmaceuticals International GmbH (Takeda) announced the launch of Rienso (ferumoxytol) in the UK, a new intravenous (IV) iron therapy to treat iron deficiency anaemia (ID A) in adult patients with chronic kidney disease (CKD). This follows marketing authorisation granted by the European Commission (EC) inJune 2012.

Clinical studies demonstrated that Rienso significantly increases haemoglobin levels as compared to oral iron [1],[2],[3] across the spectrum of CKD. Moreover, Rienso was well tolerated by CKD patients with IDA and had an overall treatment-related adverse event rate similar to oral iron treatment based on data from three pivotal Phase III [1],[2],[3] studies involving 1,726 subjects. These outcomes were further supported by additional retrospective observational data from three large haemodialysis studies conducted in the United States involving more than 8,600 [4],[5] patients and more than 33,300 administered doses of Rienso.

"While treatments for iron deficiency anaemia have been widely available for many years, this condition 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 disorder" says Professor Iain Macdougall, Consultant Nephrologist and Professor of Clinical N ephrology, King's College London. "Rienso is an effective treatment option for the management of anaemia, and news of its availability in the UK will be warmly received by the renal community."

In Europe, incidence rate of end-stage renal disease stands around 135 per 1,000,000 population with anaemia [6] being the most frequent complication. CKD is a progressive and incapacitating condition that profoundly affects the lives of patients who suffer from it. One of the reasons for its development is iron deficiency, and the prevalence [7],[8] and severity of anaemia worsens steadily as CKD advances. The treatment of anaemia in CKD has been [9] shown to reduce hospitalisation and mortality rates, and improve exercise capacity and quality of life.

"This new treatment option for IDA in CKD marks Takeda's commitment to the development of renal anaemia management. It adds to treatment choice by providing patients with an alternative solution for receivingIViron therapy" says Trevor Smith, Takeda's Head of Commercial Operations,Europe & Canada.

® About Rienso(ferumoxytol)

Rienso is anIViron therapy with an approved indication for the treatment of IDA in adult patients with CKD. The maximum total dose of ferumoxytol is 1.02g and is administered as an initial 510mg intravenous injection, followed by a second 510mg intravenous injection 2-8 days later. The 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 (AMAG). It received marketing approval as Feraheme from the US Food and Drug Administration onJune 30, 2009and was commercially launched by AMAG in the US shortly thereafter. Ferumoxytol received marketing approval in Canada inDecember 2011, in the European Union in ® June 2012and in Switzerland inAugust 2012, where it will be marketed by Takeda as Rienso .

A Summary of Product Characteristics is available on the European Medicines Agency website (http://www.ema.europa.eu).

About iron deficiency anaemia (IDA)

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 [9],[10] heart failure.

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 around 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. Areas of focus include cardiovascular and metabolic diseases, immunology and respiratory diseases, oncology and central nervous system diseases, among others. Through the integration of Millennium Pharmaceuticals and Nycomed, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.

Additional information about Takeda is available through its corporate website,http://www.takeda.com.

About Takeda UK Ltd

Takeda UK Ltd, based in High Wycombe in Buckinghamshire, is the UK subsidiary of Takeda Pharmaceutical Company and is responsible for sales and marketing of the Company's products in the UK.

Further information about Takeda UK Ltd is available athttp://www.takeda.co.uk

References

1. Spinowitz BS, Kausz AT, Baptista J,et al. Ferumoxytol for treating iron deficiency anemia in CKD.J Am Soc Nephrol2008; 19: 1599-1605. 2. AMAG Pharmaceuticals. Data on file. 3. Provenzano R, Schiller B, Rao M,et al. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients.Clin J Am Soc Nephrol2009; 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 Nephrol2011; 22: 477A-478A. Abstr FR-PO1573. ® 5. Sharma A, Bhat P, Schiller B,et al.(Ferumoxytol) administration on target hemoglobin levelsEfficacy of Feraheme and other iron parameters across 3 dialysis chains.J Am Soc Nephrol2011; 22: 485A. Abstr FR-PO1603. 6. Meguid El Nahas A, Bello AK. Chronic kidney dise ase: the global challenge.Lancet2005; 365: 331-340. 7. Qunibi WY. The efficacy and safety of current in travenous iron preparations for the management of iron-deficiency anaemia: a review.Arzneimittelforschung2010; 60: 399-412. 8. Schmidt RJ, Dalton CL. Treating anemia of chronic kidney disease in the primary care setting: cardiovascular outcomes and management recommendations.Osteopath Med Prim Care2007; 1: 14. 9. O'Mara NB. Anemia in patients with chronic kidne y disease.Diabetes Spectrum2008; 21: 12-19. 10. National Kidney Foundation. KDOQI clinical prac tice guidelines and clinical practice recommendations for anemia in chronic kidney disease.Am J Kidney Dis2006; 47:S11-15.