CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe

Rhea-AI Summary

CSL Behring (CSL) introduces a 10g prefilled syringe for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid), the #1 immune globulin prescribed for Primary Immunodeficiency (PI) and the first and only subcutaneous immune globulin (SCIg) treatment approved for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in the U.S.

Positive

• Hizentra is the top prescribed immune globulin for PI in the U.S.
• The 10g prefilled syringe for Hizentra provides flexibility and convenience for patients managing PI and CIDP.
• The availability of the 10g prefilled syringe addresses the unmet needs of people living with rare diseases.

Negative

• None.

-    Hizentra^® is the #1 immune globulin prescribed for Primary Immunodeficiency (PI) in the U.S.
-    Hizentra is the first and only subcutaneous immune globulin (SCIg) treatment approved for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in the U.S.

KING OF PRUSSIA, Pa., Jan. 3, 2024 /PRNewswire/ -- CSL Behring, a business unit of global biotechnology leader CSL, today announced the availability of a 10g prefilled syringe for Hizentra^® (Immune Globulin Subcutaneous [Human] 20% Liquid). The Hizentra prefilled syringes provide people living with Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) the ability to elevate their treatment experience by eliminating the need to draw medication from vials. CSL Behring now has a wide range of prefilled syringe sizes to help meet the individual needs of people living with PI or CIDP including a 1g, 2g, 5g and 10g.

Hizentra offers the convenience of at-home infusions under the skin for individuals managing PI or CIDP. This eliminates the need to travel to an infusion center or locate a vein, which is a benefit for those who may have venous access issues. Hizentra is the first and only self-administered immunoglobulin treatment for CIDP maintenance.

"The availability of the 10g prefilled syringe is CSL Behring's latest development in helping the rare disease community effectively manage PI and CIDP, as some patients may require treatment at a higher volume," said Bob Lojewski, Senior Vice President and General Manager, North America, CSL Behring. "We understand how important flexibility and convenience are in treatment options for people managing these lifelong conditions, and milestones such as this continue to reinforce Our Promise to address the unmet needs of people living with rare diseases."

The availability of a 10g prefilled syringe comes at a time when people living with PI and CIDP seek more convenient treatment options. According to a Harris Poll survey of 100 adults living with CIDP, 72% said that administering treatment at home is extremely/very important to them. In a separate survey of 52 people living with PI who have used both SCIg and intravenous immunoglobulin treatment (IVIg), almost 80% said they preferred SCIg over IVIg.

Those interested in learning more about treatment with Hizentra should discuss with their physicians. For more information, please visit Hizentra.com.

About Primary Immunodeficiency (PI)
PI diseases are a group of more than 450 rare, chronic disorders in which part of the body's immune system is missing or malfunctioning. Patients with PI commonly have frequent infections, reoccurring infections, infections that won't go away or unusually severe infections. As a result, patients may face repeated courses of antibiotics or be hospitalized for treatment. Many people living with PI have missed school, work or time with family and friends due to their PI.

About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
CIDP is a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord) and damages the protective covering of the nerves known as the myelin sheath. This may result in numbness or tingling, muscle weakness, fatigue and other symptoms. CIDP symptoms can worsen over time, leading to significant activity limitations and a decreased quality of life. CIDP can occur at any age and is more common in men than in women. Approximately 30% of CIDP patients progress to wheelchair dependence if not treated. The GBS|CIDP Foundation estimates that the incidence of new CIDP cases is as high as two in 100,000 people, with the accumulation of cases over time resulting in prevalence as high as nine in 100,000 in some areas.

About the CIDP Survey
The survey was conducted on behalf of CSL Behring of 100 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients and 100 neurologists/neuromuscular specialists. The survey took place between February 27, 2023 and March 15, 2023. Patients were identified and recruited directly by treating physicians. Both patients and physicians were fully screened for eligibility. The survey qualification criteria for patients include being age 18+, residency in the U.S. and CIDP diagnosis. The survey qualification criteria for physicians include that they practice in the U.S., are duly licensed, are neurologists/neuromuscular specialists and regularly see at least one patient with CIDP.

About the PI Survey
The survey was conducted on behalf of CSL Behring between August 4 and September 22, 2021, among 104 PI patients that have ever received immune globulin treatment, including IVIg (n=65), SCIg in glass vials (n=65), and/or SCIg in PFS (n=33). All participants were U.S. residents over the age of 18.

About Hizentra^® 
Registered in more than 60 countries, Hizentra is the most prescribed subcutaneous immunoglobulin for primary immunodeficiency (PI) in the U.S. It has a proven track record of safety, efficacy, and tolerability. Hizentra was first approved by the U.S. FDA in March 2010 for the treatment of patients with PI and was approved in March 2018 for the treatment of adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment. For more information about Hizentra, including the U.S. prescribing information, visit www.hizentra.com.

Important Safety Information (ISI)

WARNING: Thrombosis (blood clots) can occur with immune globulin products, including Hizentra. Risk factors can include: advanced age, prolonged immobilization, a history of blood clotting or hyperviscosity (blood thickness), use of estrogens, installed vascular catheters, and cardiovascular risk factors.

If you are at high risk of blood clots, your doctor will prescribe Hizentra at the minimum dose and infusion rate practicable and will monitor for signs of clotting events and hyperviscosity. Always drink sufficient fluids before infusing Hizentra.

See your doctor for a full explanation, and the full prescribing information for complete boxed warning.

Hizentra^®, Immune Globulin Subcutaneous (Human), 20% Liquid, is a prescription medicine used to treat:

• Primary immune deficiency (PI) in patients 2 years and older
• Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

Treatment with Hizentra might not be possible if your doctor determines you have hyperprolinemia (too much proline in the blood), or are IgA-deficient with antibodies to IgA and a history of hypersensitivity. Tell your doctor if you have previously had a severe allergic reaction (including anaphylaxis) to the administration of human immune globulin. Tell your doctor right away or go to the emergency room if you have hives, trouble breathing, wheezing, dizziness, or fainting. These could be signs of a bad allergic reaction.

Inform your doctor of any medications you are taking, as well as any medical conditions you may have had, especially if you have a history of diseases related to the heart or blood vessels, or have been immobile for some time. Inform your physician if you are pregnant or nursing, or plan to become pregnant.

Infuse Hizentra under your skin only; do not inject into a blood vessel. Self-administer Hizentra only after having been taught to do so by your doctor or other healthcare professional, and having received dosing instructions for treating your condition.

Immediately report to your physician any of the following symptoms, which could be signs of serious adverse reactions to Hizentra:

• Reduced urination, sudden weight gain, or swelling in your legs (possible signs of a kidney problem).
• Pain and/or swelling or discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, or numbness/weakness on one side of the body (possible signs of a blood clot).
• Bad headache with nausea; vomiting; stiff neck; fever; and sensitivity to light (possible signs of meningitis).
• Brown or red urine; rapid heart rate; yellowing of the skin or eyes; chest pains or breathing trouble; fever over 100°F (possible symptoms of other conditions that require prompt treatment).

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

The most common side effects in the clinical trials for Hizentra include redness, swelling, itching, and/or bruising at the infusion site; headache; chest, joint or back pain; diarrhea; tiredness; cough; rash; itching; fever, nausea, and vomiting. These are not the only side effects possible. Tell your doctor about any side effect that bothers you or does not go away.

Before receiving any vaccine, tell immunizing physician if you have had recent therapy with Hizentra, as effectiveness of the vaccine could be compromised.

Please see full prescribing information for Hizentra, including boxed warning and the patient product information.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958.

About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSLBehring.

Media Contact
Etanjalie Ayala 
Mobile: +1 610 297 1069 
Email: etanjalie.ayala@cslbehring.com

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SOURCE CSL Behring

FAQ

What is the significance of the 10g prefilled syringe introduced by CSL Behring for Hizentra?

The 10g prefilled syringe provides flexibility and convenience for patients managing Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

What are the benefits of Hizentra for people living with PI and CIDP?

Hizentra offers the convenience of at-home infusions under the skin, eliminating the need to travel to an infusion center or locate a vein, which is beneficial for those who may have venous access issues.

What feedback was received from surveys regarding the preference for SCIg over IVIg?

Almost 80% of people living with PI preferred SCIg over IVIg, indicating a strong preference for subcutaneous immune globulin treatment.