ZLB Behring Release: Phase III Clinical Study Shows Vivaglobin(R), A New Subcutaneous Immunoglobulin, Is Safe And Effective In Treating Patients With Primary Immunodeficiency
KING OF PRUSSIA, Pa., March 6 /PRNewswire/ -- Data from a Phase III clinical research study, presented yesterday at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in Miami Beach, Florida, demonstrated the safety and efficacy of new Vivaglobin® (Immune Globulin Subcutaneous [Human]), an immunoglobulin replacement therapy for treating patients with primary immunodeficiency (PI). Vivaglobin recently became the first and only Food and Drug Administration-approved subcutaneous (SC) Immunoglobulin (Ig) treatment and can be safely self-administered by PI patients under a physician's care in the United States.
In the study, 65 patients self-administered Vivaglobin at home every week for 12 months, for a total of 3,655 infusions. The annual rate of serious bacterial infections was 0.04 per patient per year, and the annual rate of any infection was 4.4 episodes per patient per year. No related serious adverse events were reported.
Patients Prefer SCIg
Patients in the trial who were assessed for health-related quality of life reported increases in general health and showed a preference for SC administration over IV administration.
"The results of the North American study demonstrate that SCIg is safe and highly effective in preventing serious infections in patients with antibody deficiency," said Hans Ochs, M.D., of the University of Washington, lead author of the study. "It is anticipated that patients who do not tolerate intravenous infusions can be safely treated with SCIg at home. This study further shows that a significant percentage of patients prefer the subcutaneous self-administration at home over intravenous infusions in a center, and that this results in a true quality-of-life benefit."
The new data presented are based on further analysis of the data ZLB Behring submitted to the Food and Drug Administration in seeking marketing approval for Vivaglobin. Those data were peer-reviewed and published in the January 2006 issue of the Journal of Clinical Immunology.
About Vivaglobin
Vivaglobin delivers treatment directly under the skin via a small, portable pump, offering a safe and effective alternative to intravenous infusions of immunoglobulin, a life-sustaining therapy that has become the standard care of therapy for the people living with PI. Vivaglobin represents a new treatment option for patients who suffer intolerable side effects from the IV method or whose veins are difficult to access, such as small children. Vivaglobin is also appropriate for those who want the freedom and convenience of safe home self-administration of Ig replacement therapy.
As with all immune globulin products, Vivaglobin® is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations and in persons with selective immunoglobulin A deficiency who have known antibody against IgA. If anaphylactic or anaphylactoid reactions are suspected, discontinue administration immediately and treat as medically appropriate.
Vivaglobin® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In clinical trials, the most frequent adverse event was injection-site reaction, consisting of mild or moderate swelling, redness, and itching. No serious local site reactions were observed, and reactions tended to decrease substantially after repeated use. Other adverse events irrespective of causality included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash.
As with all immune globulin (Ig) products, patients receiving Ig therapy for the first time, receiving a new product, or not having received Ig therapy within the preceding eight weeks may be at risk for developing reactions including fever, chills, nausea, and vomiting. On rare occasions, these reactions may lead to shock. Such patients should be monitored in a clinical setting during the initial administration.
For more details, please see the enclosed complete prescribing information for Vivaglobin, visit http://www.vivaglobin.com, or call the ZLB Behring Medical Information Department at 1-800-504-5434.
About Primary Immunodeficiencies
PIs are a group of usually genetic disorders that cause a malfunction in part or all of the immune system, keeping the patient from fighting off infections caused by common everyday germs. 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. In some severe cases of PI, infections may result in a patient being hospitalized repeatedly. Some infections, such as meningitis, may even result in death.
About ZLB Behring
ZLB Behring is a global leader in the plasma protein biotherapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB Behring provides safe and effective plasma-derived and recombinant products and offers patients a wide range of related services. The company's broad portfolio of life-saving therapeutics is used in the treatment of individuals with hemophilia and other bleeding disorders, immune deficiency disorders, and inherited emphysema; for the prevention of hemolytic diseases for the newborn; in cardiac surgery patients; and in shock and burn victims. Additionally, ZLB Behring operates one of the world's largest, fully owned plasma collection networks. ZLB Behring is a subsidiary of CSL Limited, a biopharmaceutical company, which operates worldwide from its headquarters in Melbourne, Australia. For more information, please visit http://www.ZLBBehring.com.
Contact: Sheila A. Burke Director, Public Relations & Communications Worldwide Commercial Operations Phone: +1 610-878-4209 Mobile: 484-919-2618 Email: Sheila.Burke@zlbbehring.com
Source: ZLB Behring