CSL Behring Receives FDA Approval to Extend Shelf Life of Hizentra® to 30 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 of Hizentra^®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 24 months to 30 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S., is the only SCIg in the U.S. that can be stored at room temperature throughout its entire shelf life.

Hizentra is indicated for the treatment of primary humoral immunodeficiency (PI). PI is a group of disorders, usually genetic, that result from a dysfunctional immune system. This condition prevents patients from fighting off infections caused by common germs.

"Based on what we know patients and their healthcare providers need and want, CSL Behring continually strives to enhance the products in our extensive portfolio,” said Lynne Powell, CSL Behring Senior Vice President, North America Commercial Operations. "The ability to store Hizentra without refrigeration for up to two and a half years is a milestone that provides added convenience to busy and active patients, while serving as another example of CSL Behring’s dedication to meeting customer needs.”

Stabilized with L-proline, a naturally occurring amino acid, Hizentra can be stored at room temperature (up to 25°C [77°F]) for up to 30 months. Because no refrigeration is necessary, Hizentra is always ready to use without warming, offering patients and physicians convenience and portability.

"Since transitioning to Hizentra, I have the freedom to choose the time of day and in what setting I self-infuse my therapy,” said Hizentra patient Jean Stefanic. "The convenience this product offers fits my busy schedule and helps me lead a normal life.”

The sBLA for Hizentra was based on a study assessing the product’s stability for 30 months. Physicochemical, biological and immunological parameters were assessed under controlled conditions at 25°C (77°F). The data generated from this study demonstrated that when Hizentra is stored at room temperature (up to 25ºC [77ºF]) and protected from light, it is stable for up to 30 months.

Hizentra with 30-month shelf life packaging is expected to be available later this year. Current Hizentra patients are encouraged to contact their physician with any questions regarding the shelf life of their current supply.

Hizentra is part of the immunoglobulin (Ig) franchise for CSL Behring. This comprehensive Ig product portfolio also includes the first proline-stabilized intravenous immunoglobulin. CSL Behring manufactures Hizentra at its state-of-the-art facility in Bern, Switzerland, where advanced technologies are applied to further ensure product safety and a robust and steady supply. This facility represents the long-term commitment of CSL Behring to patients around the world who use immunoglobulins to manage their medical conditions.

For more information about Hizentra, visit www.hizentra.com.

Important Safety Information

Hizentra®, Immune Globulin Subcutaneous (Human), is indicated as replacement therapy for the treatment of patients with primary humoral immunodeficiency.

Hizentra is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations or components of Hizentra, and in persons with selective immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity. If anaphylactic reactions are suspected, administration should be discontinued immediately and the patient treated as medically appropriate. Because Hizentra contains the stabilizer L-proline, it is also contraindicated in patients with hyperprolinemia.

Hizentra should be administered subcutaneously only.

Hizentra is derived from human plasma. The risk of transmission of infectious agents including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be eliminated completely.

The most common drug-related adverse reactions, observed in 5 percent or more of subjects in the clinical study, were local injection-site reactions, headache, vomiting, pain, and fatigue.

Monitor patients for reactions associated with IVIg treatment that might occur with Hizentra, including renal dysfunction/failure, thrombotic events, aseptic meningitis syndrome (AMS), hemolysis and transfusion-related acute lung injury (TRALI).

For full prescribing information, visit www.hizentra.com/consumer/prescribing-information.aspx.

About Primary Immunodeficiency

Primary immunodeficiency (PI) is a group of more than 150 diseases that affect the cells, tissues and proteins of the immune system. In people with PI, the immune system is either absent or functioning inadequately, leaving them more susceptible to infection. 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. Collectively, PIs affect an estimated 10 million people worldwide, and the incidence is estimated to be 1 in 10,000. For more information on PI, please visit www.cslbehring.com or contact the leading PI patient advocate groups in the U.S., the Immune Deficiency Foundation and the Jeffrey Modell Foundation.

About CSL Behring

CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.