The Food and Drug Administration has approved Hizentra as the first subcutaneously administered human immunoglobulin maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP), according to a statement from its manufacturer, CSL Behring.
was approved at doses of 0.2 and 0.4 g/kg per week because of the strength of the phase 3 (Polyneuropathy and Treatment with Hizentra) clinical trial and the PATH extension study, which is still ongoing. PATH is the largest and longest running randomized study of patients with CIDP. The studied the safety, efficacy, and tolerability of the two different doses of the subcutaneous immunoglobulin in 172 patients.
There were markedly lower rates of CIDP relapse or withdrawal for any reason during Hizentra treatment among patients taking a high dose of 0.4 g/kg weekly (39%; P less than .001) and those taking a low dose of 0.2 g/kg weekly (33%; P less than .007), compared with those among patients taking placebo (63%). The adverse reactions that occurred in 5% or more of patients included local infusion-site reactions, headache, diarrhea, fatigue, and upper respiratory tract infections.