SMC Accepts Rienso®▼ (Ferumoxytol), Offering Eligible Patients an Alternative Treatment Choice for Managing Iron Deficiency

SMC Accepts Rienso®▼ (Ferumoxytol), Offering Eligible Patients an Alternative
   Treatment Choice for Managing Iron Deficiency Anaemia in Chronic Kidney
                                   Disease

  PR Newswire

  HIGH WYCOMBE, England, February 11, 2013

HIGH WYCOMBE, England, February 11, 2013 /PRNewswire/ --

  *Today, the SMC announced that Rienso has been accepted for restricted use
    within NHS Scotland for the treatment of iron deficiency anaemia (IDA) in
    non-haemodialysis dependent adult patients with chronic kidney disease
    (CKD) when oral iron preparations are ineffective or cannot be used
  *The clinical efficacy and safety of Rienso has been assessed in over 1,500
    subjects from its clinical development programme, and supported by
    observational data in more than 8,600 patients and 33,000 doses
    administered in clinical practice ^1-3
  *Rienso offers a convenient and cost-competitive alternative for delivering
    a repletion course of IV iron, and requires fewer bolus injections over a
    shorter period of time when compared to most other IV iron preparations
    ^1,4-8
  *Takeda looks forward to making Rienso available to patients in Scotland as
    part of its ongoing commitment to improving management of IDA

Today, Takeda UK announces the Scottish Medicines Consortium's (SMC)
acceptance of Rienso (ferumoxytol), a new intravenous ( IV ) iron therapy to
treat iron deficiency anaemia (IDA) restricted to non-haemodialysis dependent
adult patients with chronic kidney disease (CKD) when oral iron preparations
are ineffective or cannot be used. All eligible patients in NHS Scotland will
now be able to receive Rienso, offering a convenient and cost-effective
alternative to current IV iron therapies. ^1,4-8

"Rienso will be a valuable addition to the currently available therapies for
IDA as an effective and convenient method for delivering high dose iron; a
significant consideration for non-dialysis patients who maintain an
independent lifestyle. Its acceptance by the SMC will be of real benefit to
the Scottish renal community." - Professor Alan Jardine, University of
Glasgow.

Anaemia continues to place a significant burden on the daily lives of CKD
patients, despite the availability of treatments to address the condition. ^9
Effective and efficient delivery of high doses of IV iron can lead to less
disruption to the daily life of CKD patients, brought about by less time spent
away from their home, family and work. ^8 Additionally, fewer patient visits
can help improve the efficiency of service delivery leading to cost savings
for the NHS. ^8

Marketing authorisation for Rienso was granted by the European Commission on
15 June 2012. ^1 Administered as a rapid IV injection, Rienso can be given to
most adults as two x 510 mg doses administered 2-8 days apart, the benefits of
which are rapid repletion of iron stores in anaemic CKD patients, with fewer
bolus injections when compared to most other IV iron preparations. ^1,4-8
Rienso also offers the NHS a cost-competitive solution when compared to the
alternative high bolus dose IV iron. ^7

Iron deficiency is a common cause of anaemia often seen in the later stages of
CKD, and 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. ^9 Management of IDA is
therefore an important aspect of care for patients with CKD and in Scotland
alone, over 11,000 non-haemodialysis dependent CKD patients are estimated to
suffer from anaemia. ^10

"Takeda are committed to improving the lives of patients worldwide,
particularly in CKD, a profoundly debilitating condition for the patients who
suffer from it. Acceptance of Rienso by the SMC marks an important milestone
in providing physicians with a valuable alternative in the management of CKD
patients with IDA in Scotland." - Yasuhiro Fukutomi, Managing Director of
Takeda UK.

Rienso has been shown in clinical studies to significantly increase
haemoglobin levels, with a similar overall treatment-related adverse event
rate as compared to oral iron across the spectrum of CKD; based on data from
over 1,500 subjects. ^1 Compared to the most widely prescribed IV iron
preparation, the FIRST (Ferumoxytol Compared to Iron Sucrose Trial) study
demonstrated that Rienso, delivered as two injections of 510 mg within 2-8
days, had a similar safety and comparable efficacy profile to 1 g of iron
sucrose dosed as 100 mg or 200 mg over 5 to 10 injections within 2-2.5 weeks.
^11

Moreover, these data are supported by additional retrospective analyses
conducted inthe United Statesinvolving more than 8,600 patients and more
than 33,300 administered doses of Rienso. ^2,3

NOTES FOR EDITORS

Recommendation from the SMC

ADVICE : following a full submission

Ferumoxytol (Rienso ^® ) is accepted for restricted use within NHS Scotland.

Indication under review: Intravenous treatment of iron deficiency anaemia in
adult patients with chronic kidney disease.

SMC restriction : treatment of iron deficiency anaemia in non-haemodialysis
dependent adult patients with chronic kidney disease when oral iron
preparations are ineffective or cannot be used.

In two Phase III studies the mean increase from baseline in haemoglobin was
significantly higher for ferumoxytol than oral iron in non-haemodialysis
dependent patients with chronic kidney disease. A mixed treatment comparison
demonstrated equivalent efficacy outcomes for ferumoxytol versus a range of
intravenous iron preparations.

About Rienso ^®  (ferumoxytol) 

Ferumoxytol is an IV iron therapy with an approved indication for the
treatment of IDA in adult patients with CKD. When patients are iron deficient
ferumoxytol can be administered as an initial 510 mg intravenous injection,
followed by a second 510 mg intravenous injection 2-8 days later. For patients
with Hb ≤10 g/dL, or 10-12 g/dL and > 50 kg in body weight; the recommended
course of ferumoxytol is two injections of 510 mg 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. ^1

Ferumoxytol was developed by AMAG Pharmaceuticals, Inc (AMAG). ^1 It received
marketing approval as Feraheme from the United States Food and Drug
Administration onJune 30, 2009and was commercially launched by AMAG in the
United States shortly thereafter. Ferumoxytol received marketing approval
inCanadainDecember 2011, in the European Union inJune 2012and in
SwitzerlandinAugust 2012, where it will be marketed by Takeda as Rienso ^® .

A Summary of Product Characteristics is available on the website
http://www.medicines.org.uk .

About Takeda

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

Located in Osaka, Japan, Takeda Pharmaceutical Company is a research-based
global company with its main focus on pharmaceuticals. As the largest
pharmaceutical company in Japan and one of the global leaders of the industry,
Takeda is committed to strive towards better health for patients worldwide
through leading innovation in medicine.

Further information about Takeda in the UK is available at
http://www.takeda.co.uk .

References

1.Rienso Summary of Product Characteristics (SmPC). Available online at:
    http://www.medicines.org.uk . Accessed January 2013.
2.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.
3.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.
4.Venofer SmPC. Available online at: http://www.medicines.org.uk . Accessed
    January 2013.
5.CosmoFer SmPC. Availabe online at: http://www.medicines.org.uk . Accessed
    January 2013.
6.Monofer SmPC. Available online at: http://www.medicines.org.uk . Accessed
    January 2013.
7.Monthly Index of Medical Specialities (MIMS). January 2013.
8.Bhandari S. Beyond efficacy and safety - the need for convenient and
    cost-effective iron therapy in health care. NDT Plus 2011; 4(Suppl 1):
    i14-i19.
9.O'Mara NB. Anemia in patients with chronic kidney disease. Diabetes
    Spectrum 2008; 21: 12-19.
10.Scottish Intercollegiate Guidelines Network. Diagnosis and management of
    chronic kidney disease. 2008. Available online at: http://www.sign.ac.uk .
    Accessed January 2013.
11.Macdougall IC, McLaughlin J, Fortin GS, Li Z, Strauss WE. The FIRST
    head-to-head comparison study (Ferumoxytol compared to Iron Sucrose Trial)
    of the safety and efficacy of ferumoxytol compared with iron sucrose for
    the treatment of iron deficiency anemia in patients with chronic kidney
    disease. Presented November 2011 at ASN Kidney Week 2011.

Contact: Danny Stepto, Takeda: +41-79-609-9452, danny.stepto@takeda.com
 
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