> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts BLA for CSL Behring’s Hizentra
- URL: https://www.fdaweb.com/fda-accepts-bla-for-csl-behrings-hizentra/
- Published: 2017-07-19T12:00:00.000Z
- Updated: 2026-09-14T22:34:59.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5139174

FDA has accepted a CSL Behring BLA for Hizentra \[immune globulin subcutaneous (human) 20% liquid\] for treating chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. CIDP is a rare immune-mediated disorder involving peripheral nerves and the effects can worsen over time. The submission is based on data from the [PATH](http://www.cslbehring.com/newsroom/Largest-Ever-CIDP-Clinical-Study-Completed.htm?ref=fdaweb.com) (Polyneuropathy And Treatment with Hizentra) clinical trial that was designed to demonstrate the efficacy, safety and tolerability of two different doses. A long-term open label extension study is ongoing and is expected to be completed later this year. Currently, Hizentra is approved for treating patients with primary immunodeficiency.