CSL Behring announced that the Food and Drug Administration (FDA) has approved Hizentra (immune globulin subcutaneous [human] 20% liquid) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. This marks Hizentra as the first subcutaneous immunoglobulin (SCIg) approved for CIDP.
The FDA’s approval was supported by data from the Phase 3 PATH (Polyneuropathy And Treatment with Hizentra) study. The data showed a significantly lower proportion of patients experiencing CIDP relapse or withdrawal for any other reason during SCIg treatment when treated with low-dose (38.6%; P=0.007) or high-dose Hizentra (32.8%; P<0.001) compared with placebo (63.2%). In the study, Hizentra patients experienced fewer systemic adverse reactions per infusion vs IVIg treatment (2.7% vs 9.8%). Moreover, no adverse reactions were seen in 93% of the total Hizentra infusions (n=4,225).
“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,” said Lisa Butler, executive director of the GBS|CIDP Foundation International.
Hizentra is already approved to treat primary humoral immunodeficiency (eg, congenital or X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies) in adults and children aged 2 years and older. It is available as 0.2mg/mL (20%) liquid for SC infusion in single-use vials (5mL, 10mL, 20mL, 50mL).
For more information call (800) 504-5434 or visit Hizentra.com.