HATTERSHEIM, Germany – 15 March 2018 – Global biotherapeutics leader CSL Behring today announced that the European Commission (EC) has granted marketing authorization for Hizentra® [Human normal immunoglobulin (SCIg)] as the first and only subcutaneous immunoglobulin for maintenance therapy to treat chronic inflammatory demyelinating polyneuropathy (CIDP). This approval is based on data from the Phase III PATH (Polyneuropathy And Treatment with Hizentra) study, which is the largest randomised controlled clinical study in CIDP patients. Combined with the PATH extension study, the PATH program is also the longest CIDP research period to date.
CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage. 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 over a period longer than eight weeks. Hizentra was approved as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
“Hizentra will offer clinicians a safe and effective subcutaneous therapy option for patients with CIDP,” said Prof. Dr. Ivo N. van Schaik, principal investigator, and professor of neurology at the University of Amsterdam's Faculty of Medicine (AMC-UvA). “It will also allow clinicians the flexibility to adjust doses based on their patient’s clinical response and needs.”
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 one-sided 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.
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. Until now, the only immunoglobulin therapy to treat CIDP was intravenously administered, by infusion.
“Patients who were once burdened by travelling to the infusion center or hospital may now have the flexibility to self-administer their treatment at a time, place and on a schedule that’s convenient for them.” said Lisa Butler, executive director of the GBS|CIDP Foundation International. “This approval represents an important advancement in support of CIDP community.”
Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D director, CSL Limited echoed 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 Privigen®, we are proud to offer a balanced portfolio of immunoglobulin therapies for CIDP patients.”
In CIDP, a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord), the myelin sheath, the protective covering of the nerves, is damaged. 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. Approximately 30 percent of CIDP patients will progress to wheelchair dependence if not treated. It is estimated that the global prevalence for CIDP is 1.6 to 8.9 patients per 100,000 adults.
Hizentra [Human normal immunoglobulin (SCIg)], the first 20 percent SCIg developed for subcutaneous use, is registered in over 51 countries and approved to treat certain immune deficiencies and as a maintenance treatment for CIDP. Hizentra, the world's most prescribed SCIg, has a proven track record of safety, efficacy and tolerability and has over 4.8 million exposures worldwide since 2010.
Privigen [Human normal immunoglobulin (IVIg)] is the first and only 10 percent, ready to use, room-temperature stored, liquid IVIg stabilized with proline. A naturally occurring amino acid, proline has been shown to reduce IgG aggregation and dimer formation. It is available in 80 countries around the world and is used as replacement therapy for patients with primary and secondary immunodeficiencies, and as an immunomodulatory therapy for patients with chronic immune thrombocytopenic purpura (ITP), neurological disorders such as CIDP, Guillain-Barré syndrome and Kawasaki disease.
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 www.cslbehring.com and follow us on www.Twitter.com/CSLBehring.
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