Therapeutic Goods Administration Approves HIZENTRA® (Normal immunoglobulin (Human) 20%, subcutaneous injection) for the Treatment of Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

HIZENTRA, the First Subcutaneous Immunoglobulin (SCIg) Approved for CIDP

Melbourne, Australia – 17 September 2018: CSL Behring announced today that the Australian Therapeutic Goods Administration (TGA) has approved HIZENTRA for maintenance therapy to treat chronic inflammatory demyelinating polyneuropathy (CIDP). The approval was based on data from the Phase III PATH (Polyneuropathy And Treatment with Hizentra) study, which is the largest controlled clinical study in CIDP patients to date. The PATH study assessed the safety, efficacy and tolerability of HIZENTRA in patients with CIDP.1

CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage. In CIDP, the myelin sheath, or the protective covering of the nerves, is damaged, which may result in numbness or tingling, muscle weakness, fatigue, and other symptoms.The effects of CIDP can worsen over time, leading to significant activity limitations and a decreased quality of life.3 Until now, the only immunoglobulin therapy to treat CIDP was intravenously administered by infusion in a hospital setting. Today’s approval means that many Australian patients who previously had to visit a hospital to receive treatment intravenously will be able to self-administer subcutaneous immunoglobulin therapy at home.

“As a participating site for the PATH study in Australia, we were able to provide HIZENTRA to a few of our CIDP patients. After a period of self-administration training, subcutaneous administration of immunoglobulin treatment has a great potential to increase patients’ independence and to improve their quality of life. It can also resolve the fluctuating side effects encountered by some patients receiving intravenous immunoglobulin.” said Associate Professor Arman Sabet Senior Staff Specialist at Gold Coast University Hospital.

Dr Andrew Cuthbertson, Chief Scientific Officer and R&D director, CSL Limited expressed commitment to the CIDP community, stating that “CSL Behring has dedicated years to studying CIDP to bring patients a more convenient treatment option with proven efficacy and the flexibility and freedom to self-infuse.” He added, “Now, along with intravenous immunoglobulins PRIVIGEN® and INTRAGAM® 10, we are proud to offer a portfolio of therapies for CIDP patients in Australia.” 

TGA approval for HIZENTRA in CIDP follows approval in the European Union, the United States, New Zealand and Switzerland. HIZENTRA approval for patients with CIDP delivers on the CSL Behring promise to develop and provide innovative biotherapies for patients with unmet medical needs.

To achieve access for Australian patients, CSL Behring will work with Governments and other stakeholder groups to ensure CIDP patients have access to HIZENTRA as an alternative to intravenous immunoglobulin therapy in the near future.

About CIDP
CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage. The myelin sheath, the protective covering of the nerves, is damaged, which may result in numbness or tingling, muscle weakness, fatigue and other symptoms. CIDP effects can worsen over time, leading to significant activity limitations and a decreased quality of life. CIDP can occur at any age but peak prevalence is between 40 and 60 years of age and is more common in men than in women.2,3

About The PATH Study
The safety, efficacy and tolerability of HIZENTRA in patients with CIDP was assessed in PATH; a multicentre, double-blind, randomised, placebo-controlled, parallel-group phase III study.
Results from the PATH study demonstrated that after switching from IVIg the percentage of CIDP relapse or withdrawal for any other reason during SCIg treatment was significantly lower with HIZENTRA (39 percent on low-dose HIZENTRA [0.2 g/kg weekly]; 33 percent on high-dose HIZENTRA [0.4 g/kg weekly]; p values of 0.007 and 0.001 respectively, as measured by onesided Fisher’s exact tests) than with placebo (63 percent). PATH results also showed that three times as many patients preferred subcutaneous treatment over intravenous treatment.1

About HIZENTRA
HIZENTRA is indicated for:
Replacement therapy in adults and children in:
  • Primary Immunodeficiency Disease (PID) and
  • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment, and for
Immunomodulatory therapy in:
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as maintenance therapy after stabilisation with IVIg.

HIZENTRA is contraindicated in patients with a history of severe systemic allergic reactions to the active substance of HIZENTRA or to any of its excipients, or in patients with hyperprolinaemia. HIZENTRA is for subcutaneous use only. If HIZENTRA is accidentally administered into a blood vessel, patients could develop shock. Caution is recommended during infusion, in those with anti-IgA antibodies and hypersensitivity and in relation to aseptic meningitis syndrome (AMS), embolic and thrombotic events, pathogen safety, use in elderly and paediatrics, pregnancy and lactation. HIZENTRA may affect the response to live attenuated vaccines and may interfere with some serological tests. Reported adverse reactions included injection site reactions, headache, nasopharyngitis, abdominal pain, musculoskeletal, pain and rash. Please review the Product Information before prescribing.

For more information and a complete list of side effects, please see the HIZENTRA Product Information (PI) or Consumer Medicine Information (CMI) available at:
https://www.cslbehring.com.au/products/products-list

People with CIDP should speak to their doctor for further information.

PBS Information: This product is not listed on the PBS.

HIZENTRA is funded by the National Blood Authority for specific conditions which does not currently include CIDP. Please refer to the National Blood Authority for details.

References: 1. van Schaik IN et al. Lancet Neurol. 2018 Jan;17(1):35-46, 2. Dimachkie MM and Barohn RJ. Curr Treat Options Neurol. 2013 Jun;15(3):350-66 3. Santos PL et al. Arq Neuropsiquiatr. 2014 Mar;72(3):179-83

Disclosures: Associate Professor Arman Sabet has served on advisory boards for CSL Behring Australia and was an investigator for the PATH study.

PRIVIGEN (Normal immunoglobulin (Human) 10% (100 g/L), intravenous injection)
INTRAGAM 10 (Human Normal Immunoglobulin 10% (10 g/100 mL), solution for intravenous infusion)

About CSL Behring
CSL Behring is a global biotherapeutics leader that 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, 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 haemolytic 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 22,000 people doing business in more than 60 countries. For more information, visit www.cslbehring.com.au

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MEDIA CONTACT: CSL Behring
Christina Hickie, Senior Manager Communications
CSL Limited
+61 429 609 762
Christina.Hickie@csl.com.au

Date of Preparation: September 2018 ANZ-HIZ-0075