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US regulators have cleared CSL Behring’s Hizentra for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder affecting the peripheral nerves that can cause permanent nerve damage.
CSL Behring today announced that FDA approved Hizentra®as the first and only SCIg for the treatment of CIDP as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
The FDA approval was based on results from two Phase III clinical studies that focused on the use of immunoglobulin (Ig) therapy for treating CIDP – the Polyneuropathy and Treatment with Hizentra (PATH) study