FDA Approves First and Only Subcutaneous Option for CIDP

The US Food and Drug Administration has approved Hizentra (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 comes after the results from the Polyneuropathy And Treatment with Hizentra study were published. The study found that Hizentra lowered the rate of CIDP relapse or withdrawal for any other reason among patients on SCIg therapy.

“Despite available treatment options, many CIDP patients continue to struggle with daily disease and lifestyle challenges, making continued research and innovation critical,” said Lisa Butler, executive director of the GBS|CIDP Foundation International.

“The approval of Hizentra offers patients who were once burdened by traveling to the infusion center or hospital the flexibility to self-administer their treatment at a time, place, and on a schedule that’s convenient for them.”

—Amanda Balbi

Reference:

FDA approves Hizentra® (immune globulin subcutaneous [human] 20% liquid) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) [press release]. King of Prussia, PA: CSL Behring; March 16, 2018. https://www.cslbehring.com/vita/newsroom/20180316-fda-approves-hizentra-to-treat-cidp.