EU Clears First Subcutaneous Immunoglobulin (Hizentra) for CIDP

Megan Brooks


March 15, 2018

The European Commission has granted marketing authorization for human normal immunoglobulin (Hizentra, CSL Behring), the first and only subcutaneous immunoglobulin (SCIg) for maintenance therapy to treat chronic inflammatory demyelinating polyneuropathy (CIDP).

CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage. Hizentra was approved as maintenance therapy to prevent relapse of neuromuscular disability and impairment.

The approval is based on data from the phase 3 Polyneuropathy and Treatment with Hizentra (PATH) study.

As previously reported by Medscape Medical News, the PATH study showed that after switching from intravenous immunoglobulin (IVIg), the percentage of patients with CIDP relapse or withdrawal during SCIg treatment was significantly lower with Hizentra (39% with 0.2 g/kg weekly and 33% with 0.4 g/kg weekly) than with placebo (63%). 

PATH results also showed that most patients preferred SCIg over IVIg treatment.

"Hizentra will offer clinicians a safe and effective subcutaneous therapy option for patients with CIDP," Ivo van Schaik, MD, PATH principal investigator, and professor of neurology, University of Amsterdam Academic Medical Center, the Netherlands, said in a company news release. "It will also allow clinicians the flexibility to adjust doses based on their patient's clinical response and needs."

"Patients who were once burdened by traveling to the infusion center or hospital may now have the flexibility to self-administer their treatment at a time, place and on a schedule that's convenient for them," Lisa Butler, executive director of the GBS|CIDP Foundation International, said in the release.  

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