The European Commission has authorized the marketing of Hizentra (human normal immunoglobulin) as the first and only subcutaneous immunoglobulin (SCIg) for maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), after stabilization with immunoglobulin by intravenous (IVIg). The approval is based on data obtained from the phase III PATH study (Polyneuropathy And Treatment with Hizentra), the largest randomized placebo-controlled clinical trial in patients with CIDP. The results of the PATH study showed that, following the switch from intravenous to subcutaneous therapy, the rate of disease recurrence and exit from the study for any other reason was significantly lower among patients treated with subcutaneous (39% in the low dose therapy group of Hizentra [0.2 g / kg per week], 33% in the high dose therapy group [0.4 g / kg per week]) compared to the placebo group (63%).

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