The TGA has approved CSL Behring's HIZENTRA for maintenance therapy to treat chronic inflammatory demyelinating polyneuropathy (CIDP).
The company said the approval was based on data from the Phase 3 PATH (Polyneuropathy And Treatment with Hizentra) study, which is the largest controlled clinical study in CIDP patients to date.
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.
Until now, the only immunoglobulin therapy to treat CIDP was intravenously administered by infusion in a hospital setting.
In a statement, CSL Behring said the approval means 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.
According to Dr Andrew Cuthbertson, CSL's chief scientific officer and R&D director, “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.
“Now, along with intravenous immunoglobulins PRIVIGEN and INTRAGAM 10, we are proud to offer a portfolio of therapies for CIDP patients in Australia.”
The company said it will work with government and other stakeholder groups to achieve funded patient access to HIZENTRA.