CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (USFDA) requesting approval to market its 20 percent liquid formulation, Immune Globulin Subcutaneous (Human) (IgSc), in the United States for weekly replacement therapy in patients with primary immunodeficiencies (PI).
The ready-to-use, high concentration subcutaneous immunoglobulin is stabilized with L-proline, a naturally occurring amino acid and can be stored at room temperature (up to 25°C [77°F]). If approved for marketing by the USFDA, it will represent another treatment option for patients on Ig therapy who want the freedom and convenience of safe, at-home self-administration of replacement therapy.
"CSL Behring has completed four clinical trials in primary immunodeficiencies in the last four years," said Val Romberg, Head of Research & Development at CSL Behring. "Submission of this BLA reinforces our commitment to serving the PI and rare disease community. We look forward to making this new therapy available in the U.S. upon FDA approval."
Primary immunodeficiencies are a group of 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 PIs 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 (immunoglobulins) can help supplement the immune system to prevent infection in nearly three-quarters of those people living with PI whose disease is due to an antibody deficiency.
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, Communications & Public Relations
Worldwide Commercial Operations
Tel: +44 207 067 0205
Cell: 044 7702 319 850