CSL Behring announced that the FDA has approved a supplemental Biologics License Application (sBLA) to extend the shelf life for Privigen (immune globulin intravenous [Human] liquid) from 24 months to 36 months. The sBLA approval for Privigen was based on a three-year study assessing the product’s stability. Physicochemical, biological and immunological parameters were assessed during 36 months’ storage under controlled conditions at 25ºCelsius (77ºFarenheit). Over the 36 months, the IgG fraction in Privigen maintained high purity (≥98%) and no relevant amounts of aggregated IgG molecules were formed.
Privigen is indicated for the treatment of primary immunodeficiency.
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