November 27, 2009
Monofer®, a new treatment for iron deficiency anaemia, received
a positive outcome for its registration today. The decision paves
the way for Monofer® to receive national marketing authorizations
Monofer® (iron isomaltoside 1000) is the only IV iron
preparation that offers both the widest accepted dose range and no
test dose requirement1. It is indicated for the
treatment of patients with iron deficiency anaemia, and can be
administered to patients with various underlying conditions*.
Monofer® was granted a positive outcome today as part of a
decentralized procedure in 22 European countries with Sweden as
Reference Member State. Now, Pharmacosmos, the company that
developed Monofer®, expects to obtain national marketing
authorizations for Monofer® in 2010.
Lars Christensen, M.D., President and CEO of Pharmacosmos,
comments: "We are very happy to have received the positive
outcome. It marks another positive step forward in Pharmacosmos'
endeavours to continuously improve treatments for patients with
iron deficiency anaemia. There is increasing awareness among
healthcare professionals that patients suffering from iron
deficiency anaemia need increased iron dosing. By offering
convenient infusion of large doses of iron, Monofer® will
benefit many more patients than previously possible."
Anaemia is a global public health problem that has major
consequences for social and economic development2. It is
thought that 50 percent of anaemia cases are due to iron
deficiency3 - and in 2002, iron deficiency anaemia was
named as one of the major contributing factors to the global burden
Clinical studies within nephrology, gastroenterology, obstetrics
and gynaecology have indicated that 88-97 percent of the patients
with iron deficiency anaemia require 1,000 mg of iron or more to be
The efficacy and safety of Monofer® has already been documented
in clinical studies in patients with chronic kidney disease (CKD)
and congestive heart failure (CHF)7,8. Pharmacosmos'
ongoing clinical program includes additional Monofer® studies
within nephrology, oncology and gastroenterology.
Learn more about Monofer® at
Contact for further information
Lars Christensen, M.D.
President and CEO
T: +45 59 48 59 59
1) Core SPC, 2) World Health
Organization. The World Health Report 2002: Reducing risks,
promoting healthy life. Geneva, World Health Organization, 2002. 3)
Iron Deficiency Anaemia: assessment, prevention, and control. A
guide for programme managers. Geneva, World Health Organization,
2001 (WHO/NHD/01.3). 4) Quinibi W. et al. XLV ERA-EDTA Congress,
May 10-13 2008, Stockholm, Sweden. 5) Quinibi W. et al. J Am Soc
Nephrol 2007; 18: SU-PO 1029. P 813A. 6) David B. Van Wyck et al.
Large-dose intravenous ferric carboxymaltose injection for iron
deficiency anemia in heavy uterine bleeding: a randomized,
controlled trial. Transfusion 2009 advanced access. 7) Poster No.
M560, World Congress of Nephrology, May 22-26 2009, Milan, Italy.
8) Heart Failure Congress 2009, 30 May 2009 - 02 jun 2009, Nice,
* When oral iron preparations are ineffective
or cannot be used. Where there is a clinical need to deliver iron
rapidly. The diagnosis of iron deficiency anemia should be based on
appropriate laboratory tests (e.g. serum ferritin, serum iron,
transferrin saturation or hypochromic red cells).
© 2009 Pharmacosmos A/S. Monofer® is a
registered trademark of Pharmacosmos A/S.
About Pharmacosmos A/S
Headquartered in Denmark, Pharmacosmos is a family-owned,
international healthcare company with more than 50 years of
innovation and leadership in iron- and carbohydrate-based
treatments and solutions for human and animal use.
A research-based company, its ongoing R&D programme focuses
on improving the lives of patients with iron deficiency with or
without anaemia. More than 1 billion people live with iron
deficiency anaemia and it is the leading cause of death for an
estimated 180,000 people every year. This makes it one of the
largest global health challenges of our time.
Pharmacosmos has subsidiaries in the Nordics, the UK and the US
and its products are marketed in more than 80 countries across the
world. Its manufacturing facilities are approved, among others, by
the Danish Medicines Agency and the US FDA.