CSL Behring Announces FDA Approval of PrivigenTM—First Proline-Stabilized 10 Percent Liquid IVIg
—Company’s newest offering requires no refrigeration or reconstitution—
King of Prussia, PA — 27 July 2007
CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for PrivigenTM [Immune Globulin Intravenous (Human), 10% Liquid], an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI). Privigen is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding.
A 10 percent liquid preparation of polyvalent human immunoglobulin, Privigen offers healthcare professionals convenience and ease-of-use. It is the first and only proline-stabilized IVIg that is always ready for immediate use, requiring no refrigeration or reconstitution.
"Privigen is an exciting new offering to patients and healthcare professionals in the United States," said Paul Perreault, Executive Vice President of Worldwide Commercial Operations at CSL Behring. "As the leader in developing safe, high-quality, effective immune globulin therapies for use around the world, CSL Behring is proud to add yet another product to our rapidly growing portfolio. We see a strong demand for Privigen and are pleased to be bringing it to patients and other valued customers."
"With Privigen, once again, CSL Behring has answered an important need," said Mark Stein, M.D., Chief, Allergy Section at Good Samaritan Hospital in West Palm Beach Hospital in Florida. "The time savings and flexibility it provides to healthcare professionals is an important step forward. It will certainly be a welcome addition to currently available immune globulin therapy options in the U.S." Dr. Stein served as lead investigator on the Privigen clinical trial.
CSL Behring plans to launch Privigen in the first quarter of 2008. In the meantime, the company is advancing the registration of Privigen in Europe. The application is currently under review by European regulatory authorities.
The FDA approved Privigen based on results of two pivotal open-label, prospective, multi-center clinical studies. One study was performed in the United States and Europe in subjects with PI, and the other study was performed in Europe in subjects with chronic immune thrombocytopenic purpura. In the PI study, 80 adult and pediatric subjects received Privigen every three or four weeks at doses ranging from 200 mg/kg to 888 mg/kg for a maximum of 12 months. The annual rate of serious bacterial infections (defined as bacterial pneumonia, meningitis, sepsis, osteomyelitis, and visceral abscesses), the primary endpoint, was 0.08 infections per subject per year. Pneumonia was reported in three subjects, and visceral abscess, osteomyelitis, and septic arthritis in one subject each. The annual rate of any infections, a secondary endpoint, was 3.55 infections per subject per year.
In the ITP study, 57 subjects with a platelet count of ≤ 20 x 109/L received 1 g/kg Privigen twice on each of two consecutive days and were observed for 29 days. A total of 46, or 80.7% of subjects, responded to Privigen therapy with an increase of platelet count to ≥ 50 x109/L within seven days after the first study drug administration. Hemolysis occurred in eight subjects treated with Privigen in the ITP study. These cases all resolved uneventfully.
Important Safety Information
In clinical studies, Privigen has been shown to be safe. As with any medication, side effects may accompany treatment. The frequency of side effects was based on a review of 1,038 injections given during the clinical trial in the United States and Europe. Because Privigen is made from plasma, as are all commercial human polyvalent immunoglobulins, the risk of transmitting infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Privigen is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction. Such patients should only receive intravenous immune globulin with utmost caution and in a setting where supportive care is available for treating life-threatening reactions.
Boxed warning: Immune Globulin Intravenous Human (IGIV) products have been associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. While reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Privigen does not contain sucrose.
For more details and complete prescribing information on Privigen, please call the CSL Behring Medical Information Department at 1-800-504-5434.
About Primary Immune Deficiencies
These are a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system, keeping the patient from fighting off infections caused by 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. Nearly 100 types of PIs exist. Most are inherited, but in some cases the cause is unknown.
No single treatment works for all of the different types of PI. Infusions of replacement antibodies (immune globulins or Ig) can help supplement the immune system to prevent infection in nearly three-quarters of those people living with PI whose disease is tied to an antibody deficiency.
Immune Thrombocytopenic Purpura, or ITP, is an autoimmune disease in which the immune system attacks and destroys the body's own platelets, the cells that prevent bleeding in blood vessels and facilitate clotting. There are two forms of ITP: acute ITP, which resolves within six months, and chronic ITP, which most often occurs in adults and by definition lasts six months or longer. The annual incidence of ITP is 100 to 115 in every one million people. In the U.S., approximately 200,000 people have the disorder.
ITP is characterized by a low number of platelets (<30 x 109/L), usually caused by the body’s production of substances (antibodies) that coat the platelets and signal their elimination from the blood. Diagnosis of ITP is often made by excluding other possible causes of the low platelet count and bleeding. People with the disorder often have purple bruises on the skin called purpura, a sign that bleeding has occurred in small blood vessels under the skin. They can also have petechiae, small red splotches on the skin that resemble a rash.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic disease in newborns, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one
of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia.
For more information, visit www.CSLBehring.com.
Sheila A. Burke, Director Public Relations & Communications
Worldwide Commercial Operations, CSL Behring
1020 First Avenue, King of Prussia, PA 19406-0901
Nicole Symon, Account Supervisor
640 Fifth Avenue, New York, NY 10019