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

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• Publié par: takeda
• Nombre de lectures: 26
• Langue: English

Extrait

Rienso®▼ (ferumoxytol) Receives European

Marketing Authorisation for the Treatment of

Iron Deficiency Anaemia in Adult Chronic

Kidney Disease Patients

PR Newswire

LONDON, OSAKA, Japan and LEXINGTON, Massachusetts, June 22, 2012

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.