CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen® from 24 to 36 Months
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life for Privigen®, Immune Globulin Intravenous (Human), 10% Liquid, from 24 to 36 months. The approval makes Privigen the first liquid intravenous immunoglobulin (IVIg) in the U.S. that can be stored at room temperature throughout its entire 36-month shelf life.
Privigen is the first and only 10 percent liquid IVIg stabilized with proline, a naturally occurring amino-acid. The product is indicated for primary immunodeficiency (PI), a group of disorders, usually genetic, that result from a malfunction in part or all of the immune system. This condition prevents patients from fighting off infections caused by everyday germs. Privigen is also indicated for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.
Proline efficiently minimizes dimer formation (≤12% dimers) and allows storage of Privigen at room temperature (up to 25°C [77°F]) throughout its entire 36-month shelf life. Because the product does not need refrigeration, Privigen is always ready for immediate use. As a liquid IVIg, it also requires no reconstitution, which saves preparation time and minimizes product waste.
“CSL Behring has a history of developing innovative immunoglobulin therapies and we continually strive to enhance the quality of the life-saving products our patients depend on,” said Robert Lefebvre, Vice President and General Manager, U.S. Commercial Operations at CSL Behring. “Part of that commitment includes convenience for patients and health providers. The approval of an extended shelf life for Privigen is another example of our dedication to meeting customer needs.”
The sBLA for Privigen was based on a three-year study assessing the product’s stability. Physicochemical, biological and immunological parameters were assessed during 36 months’ storage under controlled conditions at 25°C (77°F). Over the 36 months, the IgG fraction in Privigen maintained high purity (≥98%) and no relevant amounts of aggregated IgG molecules were formed. Also, the use of proline at pH 4.8 inhibited dimer formation (≤12%) throughout the study period.
Privigen is part of the Ig franchise of CSL Behring. This comprehensive immunoglobulin product portfolio also includes the first 16 percent and first 20 percent subcutaneous immunoglobulin (SCIg) therapies approved in the U.S. by the FDA. CSL Behring manufactures Privigen at its state-of-the art facility in Bern, Switzerland where the most advanced technologies are applied to ensure product safety and ample supply. This facility represents the long-term commitment of CSL Behring to global Ig markets.
For more information about Privigen, including full prescribing information, visit http://www.privigen.com/privigen-pi-privigen-prescribing-information.aspx.
Important Safety Information
WARNING: Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with the administration of Immune Globulin Intravenous (Human) (IVIg) products in predisposed patients. Administer IVIg products at the minimum infusion rate possible. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIg products containing sucrose. Privigen does not contain sucrose. See full prescribing information for complete boxed warning.
Privigen is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Also monitor patients with risk factors for thrombotic events, including a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity.
Aseptic meningitis syndrome (AMS) may occur infrequently with Privigen and other IVIg treatments, and may occur more frequently with high doses and/or rapid infusion of IVIg. Hemolysis, hemolytic anemia, and pulmonary adverse events have also been reported. If transfusion-related acute lung injury is suspected, test product and patient for antineutrophil antibodies.
Privigen is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In clinical studies, the most common adverse reactions with Privigen were headache, pain, nausea, pyrexia/ hyperthermia, fatigue, chills, and anemia.
For more details and complete prescribing information for Privigen, please call the CSL Behring Medical Information Department at 1-800-504-5434.