CSL Behring: FDA Accepts sBLA for Hizentra® for Chronic Inflammatory Demyelinating Polyneuropathy

Wednesday, July 19, 2017 | Product Launches and Updates


The FDA has accepted for review CSL Behrings supplemental Biologics License Application (BLA) for Hizentra®([Immune globulin subcutaneous [Human] 20% liquid) for the treatment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. 

"We remain committed to CIDP patients and their families and the review of this application is another step towards delivering on our promise to them." said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. "We're also excited about the possibility of adding a CIDP indication for our industry-leading portfolio of immunoglobulin therapies."  

The application was based on data from the largest-ever randomized CIDP trial, PATH (Polyneuropathy And Treatment with Hizentra®).  The clinical trial was completed in March and was designed to demonstrate the efficacy, safety and tolerability of two different doses of CSL Behring's subcutaneous immunoglobulin (SCIG), Hizentra®, compared with placebo, in the maintenance treatment of CIDP patients previously treated with intravenous immunoglobulin (IVIG).

Hizentra®, the most commonly prescribed immunoglobulin therapy for primary immunodeficiencies (PI), the most prescribed SCIG worldwide, and the only 20 percent SCIG designed with the natural stabilizer L-proline, was self-administered by patients and care givers throughout the study.  Subjects were allowed to use dose volumes up to 50mL/site and infusion rates of up to 35mL/hour, to provide them with greater flexibility and autonomy to infuse when and where they choose. A long-term open label extension study is ongoing and is expected to be completed later this year.

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