CSL Behring Receives European Commission Marketing Authorization for Hizentra(R), the first 20 Percent Subcutaneous Human Immunoglobulin for Treatment of Primary and Secondary ImmunodeficienciesBy Csl Behring, PRNE
Wednesday, April 20, 2011
New high concentration, at-home therapy offers convenience to patients managing primary and secondary immunodeficiencies-rare and serious disorders affecting millions worldwide
BERN, Switzerland, April 21, 2011 - CSL Behring announced today that the European Commission has granted
marketing authorization for Hizentra(R) (Human Normal Immunoglobulin), 20
percent solution for subcutaneous injection, for treating patients diagnosed
with primary immunodeficiency (PI) as well as secondary immunodeficiencies.
This authorization is valid for all 29 European/European Economic Area member
CSL Behring is a subsidiary of CSL Limited (ASX:CSL). Hizentra is
currently marketed in the United States. It received U.S. Food and Drug
Administration approval in March 2010.
"Hizentra is an exciting new offering in Europe that represents an
effective, convenient choice of at-home subcutaneous Ig therapy for people
with primary and secondary immunodeficiencies," said Paul Perreault,
Executive Vice President, Worldwide Commercial Operations, CSL Behring.
"Because it is ready-to-use, Hizentra enables patients to infuse the product
where and when it suits them, and physicians now have another product to
select to best meet the individual needs of their patients. As a leader in
developing safe, high-quality, effective Ig therapies for use around the
world, CSL Behring is proud to add this important addition to our expanding
This high-concentration product is stabilized with L-proline, a naturally
occurring amino acid. L-proline allows Hizentra to be stored at room
temperature (up to 25 degrees C [77 degrees F]). The European Commission has
cleared Hizentra with an initial storage shelf life of two years. Because no
refrigeration is necessary, Hizentra is ready to use, offering patients and
physicians convenience and portability.
As the first 20 percent subcutaneous immunoglobulin (Ig), Hizentra
provides lower infusion volumes, combined with consistent and steady levels
of immunoglobulin resulting in effective protection against infection.
Hizentra is part of the CSL Behring immunoglobulin (Ig) franchise. This
comprehensive Ig product portfolio also includes the first U.S. FDA-approved
subcutaneous immunoglobulin and the first proline-stabilized intravenous
immunoglobulin. CSL Behring manufactures Hizentra at its state-of-the-art
facility in Bern, Switzerland, where advanced technologies are applied to
further ensure product safety and ample supply. This facility represents the
long-term commitment of CSL Behring to global Ig markets.
The European Commission approval of Hizentra was based on results from a
prospective, open-label, multicenter, single-arm, clinical study conducted in
Europe, evaluating the efficacy, tolerability, and safety of Hizentra in
adult and pediatric subjects with PI. In the study, 51 PI patients (3 to 60
years old), previously treated with IVIg or SCIg therapies, received weekly
subcutaneous infusions of Hizentra at doses equivalent to those used in
previous treatment. The primary endpoint to sustain IgG trough levels
comparable to the previous treatment was achieved (mean trough level of 8.10
g/L for Hizentra). While the mean IgG trough level increased by 17.7 percent
in patients who had been with IVIG (6.78 g/L pre-study level ), it remained
similar in patients who had been previously treated with subcutaneous Ig
(pre-study level of 8.43 g/L). No serious bacterial infections were reported
during the efficacy period in patients receiving Hizentra during the clinical
study. Almost all adverse events (98.7 percent) were mild to moderate in
About Primary Immunodeficiencies
Primary immunodeficiency (PI) is a group of more than 150 diseases that
affect the cells, tissues and proteins of the immune system.(1) In people
with PI, the immune system is either absent or functioning inadequately,
leaving them more susceptible to infection.(2) For individuals with PI - many
of them children - infections may not improve with treatment as expected, and
may keep returning. As a result, patients may face repeated rounds of
antibiotics or be hospitalized for treatment. Repeated infections can lead to
organ damage, which, over time, can become life-threatening.
Collectively, PIs affect an estimated 10 million people worldwide, and
the incidence is estimated to be 1 in 10,000.(3) For more information on PI,
please visit www.cslbehring.com. For patients with primary
immunodeficiencies, immunoglobulin replacement therapy with a product such as
Hizentra can help treat existing or chronic infections and prevent new
infections from occurring. No single treatment works for every type of PI,
but infusions of replacement antibodies (immunoglobulins) can help supplement
the immune system to prevent infection in nearly three-quarters of PI cases
that are due to antibody deficiencies.
Immunoglobulin is a blood component that has become standard immune
replacement therapy for most people living with PI, and nearly 70 percent of
PI patients receive Ig replacement therapy. Since the 1980s, the first-line
therapy for most PI patients has been intravenous immunoglobulin (IVIg), in
which immunoglobulin is delivered through a needle into the vein. Some
patients, however, cannot easily tolerate intravenous infusions due to
serious side effects or poor veins. Hizentra allows patients to use a small,
portable pump to self-administer their infusions by injection under the skin
For more information, including full Summary of Product Characteristics,
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry.
Committed to saving lives and improving the quality of life for people with
rare and serious diseases, the company manufactures and markets a range of
plasma-derived and recombinant therapies worldwide. CSL Behring therapies are
indicated for the treatment of coagulation disorders including hemophilia and
von Willebrand disease, primary immune deficiencies, hereditary angioedema
and inherited respiratory disease. The company's products are also used in
cardiac surgery, organ transplantation, burn treatment and to prevent
hemolytic diseases in newborns. CSL Behring operates one of the world's
largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary
of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in
Melbourne, Australia. For more information, visit www.cslbehring.com.
Media Contacts: Sheila A. Burke CSL Behring +1-610-878-4209 Sheila.firstname.lastname@example.org Etanjalie Ayala Weber Shandwick +1-212-445-8225 email@example.com
(1) Immune Deficiency Foundation. About primary immunodeficiencies: What
is a primary immunodeficiency?
www.primaryimmune.org/about_pi/about_pi.htm. Accessed February 2011.
(2) National Institute of Child Health & Human Development. Primary
Immunodeficiency: What is primary immunodeficiency?
(3) Jeffrey Modell Foundation. Primary Immunodeficiency Resource Center.
Accessed February 2011.
Tags: April 21, Bern, Csl Behring, Switzerland