Posted by Michael Wonder on 18 Mar 2018
FDA approves Hizentra (immune globulin subcutaneous [human] 20% liquid) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy
16 March 2018 - First and only subcutaneous immunoglobulin approved for the treatment of CIDP based on the largest controlled clinical study in CIDP.
Global biotherapeutics leader CSL Behring today announced that the U.S. FDA approved Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
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. CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage.
