Now approved by Health Canada: Hizentra®

Now approved by Health Canada: Hizentra® (Subcutaneous Immunoglobulin [Human] 20% Liquid) for the Treatment of Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for maintenance therapy

Ottawa, ON – October 10, 2018

Global biotherapeutics leader CSL Behring announced that Hizentra® (Subcutaneous Immunoglobulin [Human] 20% Liquid) has been approved for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in Canada. The approval was based on data from the Phase III PATH (Polyneuropathy And Treatment with Hizentra®) study, which is the largest controlled clinical trial in CIDP patients to date. CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage. The recommended subcutaneous dose range for the treatment of CIDP is 0.2 to 0.4 g/kg (1 mL to 2 mL/kg) body weight per week.

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. Approximately 30 percent of CIDP patients will progress to wheelchair dependence if not treated. [1] It is estimated that approximately 8.9 people per 100,000 are affected by the disease with a yearly incidence of 1.6/100,000.[2]

“The approval of Hizentra® in Canada marks an important milestone for patients struggling with the disabling neurological effects of CIDP,” said Dr. Vera Bril, investigator in the PATH trial and Professor of Medicine (Neurology) at the University of Toronto.

 “Continued research and innovation is critical for people living with debilitating neuromuscular diseases like CIDP, so we must encourage companies to keep investing in Canadian research” said Donna Hartlen, executive director of the GBS|CIDP Foundation Canada. “The approval of Hizentra for CIDP now offers patients an option that will allow them to administer their treatment at home.”

Hizentra® is currently approved in 51 countries for the treatment of certain immune deficiencies. For more information about access to Hizentra®, please contact the HizentraCARE Program at 1-888-490-4105 or via email at hizentra-care@innomar-strategies.com . For our Canadian product monograph, click here.

Important Information for Canada

Hizentra® (Subcutaneous Immunoglobulin [Human] 20% Liquid), is indicated for:

  • Treatment of Primary and Secondary Immune Deficiency
  • The treatment of patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.

 

About CSL Behring

CSL Behring is a global biotherapeutics leader 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; USOTC:CSLLY), headquartered in Melbourne, Australia, employs nearly 20,000 people, and delivers its life-saving therapies to people in more than 60 countries. For more information visit cslbehring.com.

 

Media Contact
Jennifer Purdue
Office: +1 610 878 4802
Mobile: +1 610 306 9355
Email: jennifer.purdue@cslbehring.com



[1] What is Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)?. GBS/CIDP Foundation International. 2017; https://www.gbs-cidp.org/cidp/.

[2] Incidence and prevalence of CIDP and the association of diabetes mellitus (2009). ncbi.nlm.nih.gov/pmc/articles/PMC2707109/. Accessed July 2018.