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CSL Behring: Privigen(R) Demonstrates Efficacy and Tolerability Among Patients With Various Immunodeficiencies, Data Show


10/7/2010 6:38:00 AM

ISTANBUL, Oct. 7 /PRNewswire/ --Privigen®, the first and only 10% liquid intravenous immunoglobulin (IVIg) therapy stabilized with proline, is effective and well tolerated in patients with several primary and secondary immunodeficiencies, according to data presented today at the XIVth Meeting of the European Society for Immunodeficiencies. Results also demonstrate that Privigen offers significant protection against infection.

In a separate observational study, patients reported higher overall satisfaction with Privigen compared to previous treatments, along with fewer adverse events and improvements in quality of life. Even at higher rates of infusion, Privigen tolerability appeared superior to Sandoglobulin.

"Some patients have difficulty tolerating infusions at high rates, experiencing side effects such as general tiredness and long-lasting headaches," said Bodo Grimbacher, MD, Professor, Division of Immunology, Royal Free Hospital NHS Trust, London, and study investigator. "Our observation suggests that Privigen allows for higher infusion rates, substantially reducing the time needed for infusions."

Privigen is approved in the European Union, Switzerland, Canada and the United States for treating patients diagnosed with primary immune deficiency (PID) and immune thrombocytopenic purpura (ITP). In Europe, Privigen is also approved for treating Guillain-Barre Syndrome and Kawasaki-Syndrome.

Study Design

In an interim analysis of an ongoing, multicenter, observational study to evaluate the efficacy and tolerability of Privigen, 76 patients received a total of 371 Privigen infusions. Overall, infection incidence decreased following initiation of treatment with Privigen compared with 6 months prior to the study (37 infections versus 160 infections). Patients who had not received any IVIg treatment for 6 months prior to study entry, and who received Privigen for at least 3 months, experienced significantly fewer infections during the study period than before study entry. Efficacy and tolerability were judged as very good or good in 91 percent and 88 percent of patients, respectively. Adverse events were reported for 17 of the 371 infusions.

Findings from a second observational study examined 35 patients receiving intravenous replacement therapy who were switched from Sandoglobulin® NF liquid (12% IgG) to Privigen without dose adjustment. Results indicate that a large proportion of patients could not tolerate infusion at rates higher than 0.5 mL/kg/h with Sandoglobulin, due to side effects. In contrast, some patients were also able to infuse Privigen safely at an infusion rate of 7.2 mL/kg/h for more than 30 minutes, without compromising tolerability. Approximately 70 percent of patients were able to infuse higher rates with Privigen, substantially reducing the time for infusion. Anecdotal feedback also indicated that patients experienced fewer adverse events, reported improvements in their quality of life and reported higher overall satisfaction following a switch to Privigen.

About Privigen

Privigen is the first and only 10 percent liquid IVIg stabilized with L-proline, a naturally occurring amino-acid. Privigen is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. In clinical studies, the most common adverse reactions with Privigen were headache, pain, nausea, pyrexia/ hyperthermia, fatigue, chills and anemia.

About Primary Immunodeficiencies

Primary immunodeficiencies (PIs) are a group of more than 150 diseases that affect the cells, tissues and proteins of the immune system. In people with PI, the immune system is either absent or functioning inadequately, leaving them more susceptible to infection. 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.

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.

Contact:

Sheila A. Burke, Director, Communications & Public Relations

Worldwide Commercial Operations

CSL Behring

C: 484-919-2618

O: 610-878-4209

Sheila.Burke@cslbehring.com



SOURCE CSL Behring


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