Global biotherapeutics leader CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s clinical efficacy supplement to its Biologics License Application (BLA) for Privigen® [Immune Globulin Intravenous (Human), 10% Liquid], its intravenous immunoglobulin (IVIg). The supplement seeks to obtain approval for a new indication – treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare and progressing disease that may cause permanent nerve damage. If approved, Privigen® would be indicated for the treatment of patients with CIDP to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. This would be the third approved indication for Privigen® in the US, after primary immunodeficiency (PI) and immune thrombocytopenic purpura (ITP).
Trial data used to support the supplement includes CSL Behring’s PRIMA and PATH studies, both focused on using immunoglobulin (Ig) therapy for treating CIDP. Results from the PRIMA study, a prospective, multicenter, single-arm, open-label Phase III study, suggest that Privigen® may help decrease weakness and loss of motor function in people with CIDP. Data from the recently completed PATH study will be used to further support the efficacy, safety and tolerability of Privigen® in the treatment of CIDP.
“CSL Behring is committed to building a leading neurology franchise and the approval of Privigen® for CIDP will be a significant step in providing valuable options for patients and physicians to treat neurological conditions,” said Charmaine Gittleson, Senior Vice President Global Clinical Development, CSL Limited. “The possibilities for innovating new uses for IVIg therapy are growing and this expansion into CIDP is another way we can deliver on our promise to meet the needs of patients with rare and serious diseases.”
Privigen® has been approved to treat CIDP in Europe since 2013.
Privigen® is the first and only 10 percent, ready to use, room-temperature stored, liquid IVIG stabilized with proline, a naturally occurring amino-acid. In the United States, it is used as replacement therapy for patients with primary immunodeficiencies, and as an immunomodulatory therapy for patients with chronic immune thrombocytopenic purpura (ITP). It is available in over 70 countries around the world for treating these and other rare diseases.
Important Safety Information
Immune Globulin Intravenous (Human), 10% Liquid, Privigen®, is indicated as replacement therapy for patients with primary immunodeficiency (PI) associated with defects in humoral immunity, including but not limited to common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Privigen® is also indicated to raise platelet counts in patients with chronic immune thrombocytopenic purpura (ITP).
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin products, including Privigen®. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of human immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products that contain sucrose. Privigen® does not contain sucrose.
- For patients at risk of thrombosis, renal dysfunction or renal failure, administer Privigen® at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
See full prescribing information for complete boxed warning.
Privigen® is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA, who have had hypersensitivity reactions. Patients with IgA deficiency and antibodies to IgA are at greater risk of severe hypersensitivity and anaphylactic reactions.
Privigen® is derived from human plasma. The risk of transmission of infectious agents cannot be completely eliminated. In clinical studies of patients being treated with Privigen, common adverse reactions included headache, nausea, vomiting, elevated body temperature and fatigue.
For full prescribing information for Privigen®, including the boxed warning and the patient product information, visit http://www.privigen.com/professional/prescribing-information.aspx
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
About CSL Behring
CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs more than 16,000 people with operations in more than 30 countries. For more information visit www.CSLBehring.com and follow us on www.Twitter.com/CSLBehring.