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Baxter Healthcare SA

Kiovig, Baxter's new ivig Product receives unanimous postive opinion in Europe as replacement therapy for immunodeficiencies and for immunomodulation in immune-mediated deseases

Zurich (ots)

Baxter Healthcare S.A. announced today that
Baxter"s ready-to-use liquid 10% Intravenous Immunoglobulin (IVIG),
has received unanimous positive opinion for marketing authorization
from the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMEA). Once licensed, the therapy will be
marketed under the name KIOVIG.  It is the first IVIG that will be
licensed through the EMEA's centralized approval process of the EMEA.
The CHMP has recommended that Baxter's new IVIG be indicated for
replacement therapy in primary immunodeficiency disorders, myeloma or
Chronic Lymphocytic Leukemia (CLL) with severe secondary
hypogammaglobulinemia and recurrent infections, children with
congenital AIDS and recurrent infections, Idiopathic Thrombocytopenic
Purpura (ITP) in children or adults at high risk of bleeding or prior
to surgery to correct the platelet count, Guillain Barré Syndrome,
Kawasaki Syndrome and allogeneic bone marrow transplantation.
The product offers convenience for healthcare professionals and
patients: the ready-to-use preparation eliminates the need for
reconstitution and its 10% concentration allows for reduced infusion
time when compared to 5% concentrations.  In addition, the
formulation is free of added sugar, sodium and preservatives, and the
packaging is latex-free.  It's efficacy, and tolerability has been
demonstrated in multi-center clinical trials in Europe and the United
States.
"Baxter is excited about this endorsement from the CHMP, as it
means that we are one step closer to bringing this new advance in the
treatment of immunodeficiencies and certain autoimmune diseases to
both physicians and patients in Europe," said Jim Utts, President of
Baxter Europe.
A CHMP recommendation serves as the basis for European Commission
approval, which typically follows in approximately 90 days. Approval
from the European Commission will allow Baxter to market the therapy
in all 25 European Union member states, as well as Norway and
Iceland.
Baxter had received regulatory approval from the U.S. Food and Drug
Administration (FDA) in May 2005, and the therapy was launched in the
United States in September.  A submission for approval has also been
made to Swissmedic, the Swiss Agency for Therapeutic Products in
February 2005 as well as to Health Canada's Drug Directorate in
December 2004.
ABOUT Baxter's liquid 10% IVIG
The product is a ready-to-use, sterile preparation of highly
purified and concentrated immunoglobulin G (IgG) antibodies. It is
processed from human plasma and contains a broad spectrum of IgG
antibodies against bacterial and viral antigens. Assuring state of
the art quality standards for the manufacture begins with the donor
selection process and continues throughout plasma collection, which
only occurs at licensed plasma collection facilities.  To further
support the margin of safety, three validated, independent and
effective virus inactivation/removal steps have been integrated into
processing and formulation.
ABOUT PRIMARY IMMUNODEFICIENCY DISORDERS
Primary immunodeficiency disorders encompass more than 100
diseases caused by an immune system that does not function correctly.
In Europe, PI affect approximately one in 500 persons, and experts
estimate that another one in 500 are yet undiagnosed. For the EU,
this is equivalent to 1.5 million affected individuals, 50 percent of
whom are undiagnosed.  IVIG therapy can restore IgG levels to normal
or near normal, helping the immune system function properly and
prevent infections or combat them when they occur.
ABOUT BAXTER
Baxter Healthcare S.A. is the principal European operating
subsidiary of Baxter International Inc. Baxter International Inc.,
through its subsidiaries, assists health-care professionals and their
patients with treatment of complex medical conditions, including
cancer, haemophilia, immune disorders, kidney disease and trauma. The
company applies its expertise in medical devices, pharmaceuticals and
biotechnology to make a meaningful difference in patients' lives.
(Baxter and KIOVIG are trademarks of Baxter International Inc.)
This release includes forward-looking statements concerning
further approvals of and the availability of KIOVIG. The statements
are based on assumptions about many important factors, including the
following, which could cause actual results to differ materially from
those in the forward-looking statements: completion of final
regulatory approvals; development issues that may arise in bringing
the therapy to market; and other risks identified in the company's
most recent filing with the Securities and Exchange Commission on
Form 10-Q. The company does not undertake to update its
forward-looking statements.

Contact:

Dr. Ulrike Engels-Lange, Baxter
Tel.: +49/89/31701/464
Baxter Healthcare SA
Hertistrasse 2
8304 Wallisellen
SWITZERLAND
+41/1/878'60'00

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