EMA approves fortnightly dosing option for CSL’s Hizentra

5 December 2013
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Plasma-protein specialists CSL Behring, a subsidiary of Australia’s CSL Ltd (CSL: AX), announced today that the European Medicines Agency has expanded the administration options for Hizentra (human normal immunoglobulin, SCIg, 20% liquid) to include dosing once every two weeks.

Hizentra initially received EMA approval in 2011 as a 20%, once weekly SCIg replacement therapy for adults and children with primary immunodeficiency (PID), as well as secondary immunodeficiencies, to help treat existing or chronic infections and prevent new infections from occurring. It was approved for use in Japan by the Japanese Ministry of Health, Labor and Welfare (MHLW) in September.

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