News Room
04 March 2010
CSL Behring Receives FDA Approval of Hizentra™, First 20 Percent Subcutaneous Immunoglobulin Therapy
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Hizentra™, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy,
Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body. Primary immunodeficiencies constitute a group of disorders, usually genetic, that cause a malfunction in all or part of the immune system, thereby rendering the patient unable to fight off infections caused by everyday germs.
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01 March 2010
Surveys Reveal High Frequency of Prodromal Symptoms Prior to Acute Hereditary Angioedema Attacks
Patients with hereditary angioedema (HAE) experience prodromal or early warning symptoms before nearly three-quarters of their HAE attacks, according to survey findings presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. According to researchers, this high frequency suggests that prodromal symptoms may reliably indicate when to initiate treatment to help prevent an acute HAE attack.
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01 March 2010
Study Shows C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute, Successive Attacks of Hereditary Angioedema at All Body Sites
C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks and successive attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Additional pharmacokinetic data presented at the meeting confirms that C1-INH concentrate has a longer half-life than other treatment options for HAE, which protects patients from rebound attacks.
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29 December 2009
CSL Behring Awards Fourth Round of LEAD Grants
CSL Behring, a global leader in the plasma-protein biotherapies industry and a subsidiary of CSL Limited (ASX:CSL), has awarded four advocacy grants totaling $87,000 to patient organizations in the United States through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support grassroots advocacy efforts by organizations committed to helping people who use plasma-derived or recombinant therapies manage their health conditions. Since the LEAD program’s inception in 2008, CSL Behring has awarded more than $340,000 in four semi-annual grant cycles. The deadline for the fifth round of grant requests is April 30, 2010.
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09 November 2009
Patient and Healthcare Provider Convenience Focus of Packaging Enhancements for Humate-P from CSL Behring
CSL Behring has begun packaging Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex [Human]) in a more user-friendly package based on customer market research. These packaging enhancements strive to improve the convenience of treatment for people with von Willebrand disease (VWD), the most common hereditary bleeding disorder in the United States. According to the Centers for Disease Control and Prevention, VWD affects approximately 1 to 2 percent of the U.S. population.
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29 October 2009
Junior Athletes Honored by CSL Behring at National Hemophilia Foundation's Annual Meeting
CSL Behring announced today the national winners of the 8
th annual Gettin’ in the Game
SM Junior National Championship (JNC). Developed by CSL Behring, provider of the hemophilia treatment Helixate
® FS (Antihemophilic Factor, Recombinant), the JNC is a series of one-day events held throughout the country that provide hundreds of children with bleeding disorders the opportunity to participate in a golf and baseball competition.
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12 October 2009
CSL Behring Announces FDA Approval of Berinert®, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
CSL Behring

announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert
® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE), a rare and serious genetic disorder, in adult and adolescent patients. Berinert is the first and only therapy approved for this indication in the U.S. The approval is based on the results of the phase II/III prospective, double-blind placebo-controlled
International
Multi-center
Prospective
Angioedema
C1-Inhibitor
Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate. The safety and efficacy of Berinert for prophylactic therapy have not been established.
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06 October 2009
CSL Behring Solicits Proposals for LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma-protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.
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21 September 2009
Helixate FS from CSL Behring Now Available in 3000 IU Dosage Strength to Improve Patient Convenience
Hemophilia A patients who require high doses of Helixate® FS, Antihemophilic Factor (Recombinant), can now benefit from greater convenience in administering their treatment, thanks to a new 3000 IU (international unit) dosage strength. CSL Behring announced today that this new dosage strength is available in the U.S., allowing many patients to reduce reconstitution time by eliminating the need to mix and pool multiple vials of Helixate FS.
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17 August 2009
Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A
CSL Behring announced today that
Helixate
® FS

, Antihemophilic Factor (Recombinant), has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage. This new indication was granted by the FDA after determining Helixate FS is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A.
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28 July 2009
CSL Behring Awards Third Round of LEAD Grants Supporting Patient Organization Advocacy
CSL Behring, a global leader in the plasma-protein biotherapies industry, has awarded six advocacy grants totaling $100,000 to patient organizations in the United States through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support grassroots advocacy efforts by organizations that are committed to helping people who use plasma-derived and recombinant therapies to manage their health conditions. Since the LEAD program’s inception in 2008, CSL Behring has awarded more than $250,000 in three semi-annual grant cycles.
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04 May 2009
Patient Convenience Focus of New Upgrades to HeliTrax System by CSL Behring
Hemophilia A patients and their treatment providers are now better able to manage their condition, thanks to an enhanced HeliTrax™ System from CSL Behring. Patients can now track and record their treatment progress in real time anywhere that internet access is available. By using a password-protected web interface, hemophilia A patients can easily input their treatment data and monitor their condition online even when they are not carrying their handheld electronic diary.
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17 April 2009
CSL Behring Marks World Hemophilia Day with $2M Coagulation Factor Donation to World Federation of Hemophilia
In recognition of the World Federation of Hemophilia’s (WFH) progress in improving the diagnosis and treatment of hemophilia in developing countries through its Global Alliance for Progress (GAP) program, CSL Behring has committed to donating to WFH two (2) million units of factor VIII concentrate (FVIII) each year for the next three (3) years. The donation, the total value of which will be approximately $2 million, will be made using coagulation factor concentrate with a minimum shelf-life of one year.
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02 April 2009
CSL Behring to Launch Next GameFaces™ Program Challenge
CSL Behring announced it will hold its next GameFaces™ challenge from April 14 through July 7, 2009. GameFaces is a family-oriented, online initiative for people with hemophilia A. The program is designed to encourage real-life physical activity through a series of customized challenges based on the individual’s age, disease severity and current level of physical activity.
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31 March 2009
CSL Behring Seeking Proposals for LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma-protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.
More.
15 March 2009
Rapid Treatment of Hereditary Angioedema Attacks at the Onset of Prodromal Symptoms Decreases Morbidity and Mortality
The importance of recognizing prodromal symptoms and treating acute attacks of hereditary angioedema (HAE) at the onset of these symptoms was highlighted in a survey presented today at the 2009 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. While symptoms of acute HAE attacks include episodes of edema or swelling in the hands and feet, the face, the abdomen, and/or the larynx, prodromal symptoms, which occur before an attack, are often non-specific and highly-variable, according to study findings. Treatment at the onset of these early symptoms can decrease morbidity and mortality associated with this rare and serious genetic disorder.
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15 March 2009
C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute Swelling Attacks Across All Body Sites in Patients with Hereditary Angioedema, According to Study
C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2009 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Interim results from the ongoing, prospective, open label
International
Multi-center
Prospective
Angioedema
C1-Inhibitor
Trial (I.M.P.A.C.T. 2), showed a median time to the onset of symptom relief of 16 minutes for laryngeal attacks, 23 minutes for abdominal attacks, 28 minutes for facial attacks and 31 minutes for peripheral attacks, such as attacks in the hands and feet. In total, 57 patients who experienced 640 HAE attacks in any body location were studied.
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30 September 2008
CSL Behring Initiating Next Round of LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is soliciting grants to support patient access to care through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program is committed to funding grassroots advocacy efforts in the United States by providing grants to patient organizations dedicated to helping people with rare diseases who use plasma-derived or recombinant therapies to manage their conditions.
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