BUSINESS WIRE: IgPro20, the First 20 Percent Subcutaneous Immunoglobulin,
Demonstrates
Efficacy against Infections While Maintaining Tolerability in Patients with
Primary Immunodeficiency
MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS
BERICHTENDE UNTERNEHMEN VERANTWORTLICH.
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KING OF PRUSSIA, Pa. --(BUSINESS WIRE)--01.03.2010--
Data presented today suggest that 20 percent liquid formulation, Immune
Globulin Subcutaneous (Human) (SCIg), or IgPro20 effectively protects
patients with primary immunodeficiencies (PI) against infection. The 20
percent formulation, the highest Ig concentration currently available, was
also shown to sustain serum IgG levels without causing unexpected rates of
adverse events. The data were presented at the American Academy of Allergy,
Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, US.
The data were derived from a study of 49 patients (5-72 years) previously
been treated with intravenous immunoglobulin (IVIG), who received weekly
subcutaneous infusions of L-proline stabilized IgPro20. The study covered a
15-month period, including a 12-week wash-in/-out period and a 12-month
efficacy period. The primary endpoint of the study was the annual rate of
predefined serious bacterial infections (SBIs) per patient. No SBIs were
reported during the study; 96 non-serious infections were identified.
Dr. Jordan Orange, Attending Physician, Division of Immunology, Childrens
Hospital of Philadelphia stated: These data suggest that IgPro20 provides
PI patients with robust protection against infections, while the higher
concentration may allow them to infuse the product more quickly thus
potentially enhancing its convenience.
The study also showed 99 percent of adverse events (AEs) reported with
IgPro20 to be mild or moderate in intensity. The most common temporally
associated AEs were injection site reactions. No serious IgPro20-related
AEs were reported.
Primary immunodeficiencies (PIs) are a group of nearly 100 types of
disorder that result from the defective development and maturation of the
immune system. The clinical hallmark of these disorders is increased
susceptibility to infection. Immunoglobulin replacement therapy is
indicated for patients who suffer from recurrent infections due to a lack
of protective antibodies. Repeated infections can lead to organ damage,
which over time can become life-threatening. In some severe cases of PI,
infections may result in a patient being hospitalized repeatedly. Some
infections, such as meningitis, can even result in death. Most types of PI
are inherited, but in some cases the cause is unknown.
No single treatment works for all types of PI. Infusions of replacement
antibodies (immunoglobulins) can help supplement the immune system to
prevent infection in the nearly three-quarters of people living with PI
whose disease is due to an antibody deficiency.
IgPro20 is currently being reviewed by the FDA for use as weekly
immunoglobulin replacement therapy in patients with PI. If approved, it
will represent a new treatment option for patients who want the freedom and
convenience of self-administering their replacement therapy.
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 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.
[CT]
Kontakt: CSL Behring Sheila A. Burke, Director, Communications & Public
Relations Worldwide Commercial Operations Tel: 610-878-4209 Cell:
484-919-2618 Sheila.Burke@cslbehring.com or Weber Shandwick Emma
Spencer-Smith Tel: +44 207 067 0307 espencer-smith@webershandwick.com
Pressekontakt:
BUSINESS WIRE
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www.vwd.comPermalink: http://www.ddpdirect.de/business_wire_igpro20_the_first_20_percent_subcutaneous_immunoglobulin_demonstrates_55748.html (Dies ist eine über ddp direct verbreitete Pressemitteilung. Für denInhalt ist ausschließlich das herausgebende Unternehmen verantwortlich.) ddp direct - mehr Medien
Montag, 1. März 2010
BUSINESS WIRE: IgPro20, the First 20 Percent Subcu...
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